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BiomarCaRE Cohorts

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BiomarCaRE Cohorts


General Population Based Cohorts

ATBC

Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study: The ATBC Study is a cohort of male smokers (aged 50-69 years) recruited in 1985-1988. The participants were screened from the total male population aged 50-69 years living in southern and western Finland (N = 290,406) through a postal questionnaire on their smoking habits and willingness to participate. Smokers of at least 5 cigarettes per day and willing to participate were invited to the local study center for further evaluation of their eligibility. Men were excluded due to a history of cancer or serious disease limiting their ability to participate or use of excess vitamin supplements. In all, 29,133 men were randomized to receive in a controlled trial design either alpha-tocopherol, or beta-carotene, or both, or placebo, and of them 99.9% donated a baseline serum sample (Round 1). In 1986-1993 a random intermediate serum sample was collected from 3701 participants (12.7%) known as Round 2. A whole blood sample was collected in 1992-1993 from 70.2% of the original cohort comprising 20,167 participants (Round 3). Men were prospectively followed up for cardiovascular and cancer endpoints until 2004 using record linkage to national Hospital Discharge Register, Cancer Registry, and Register of Causes of Death with validation described in (1, 2, 3). http://www.thl.fi/publications/morgam/cohorts/full/finland/fin-atba.htm http://atbcstudy.cancer.gov/


Caerphilly

Caerphilly Prospective Study (CAPS): The Caerphilly cohort is a prospective population based cohort from Wales United Kingdom (4). Men aged 56-70 years in 1989-93 were selected from the general population of Caerphilly in South Wales (population 40,000) based on their date of birth from electorial registers and private census. Phase 3 (N=2,171) was collected in 1989-93 and re-examined 10 years later in 2002-2004 (Phase 5, N=1,225) taking repeated measurements of several risk factors and biomarkers using blood samples stored at -70°C. Follow-up for deaths was performed by the Office of National Statistics and for non-fatal cardiovascular events using data linkage of hospital and GP records with validation by a study medical committee. Follow-up has been completed to February 2012. http://www.thl.fi/publications/morgam/cohorts/full/uk/unk-caea.htm



EGCUT Estonia

Estonian Genome Center of the University of Tartu (EGCUT) – The Estonian Biobank: The Estonian Biobank is a population-based biobank of the Estonian Genome Center of the University of Tartu (EGCUT). The project is conducted in accordance with the Estonian Gene Research Act (www.biobank.ee) and all subjects have been recruited randomly, on voluntary basis by general practitioners and physicians in hospitals. As of June 2013 the number of individuals is 51 713, which represents about 5% of Estonia's adult population. Phenotyping of subjects (18-103 years of age) was performed by Computer Assisted Personal interview (CAPI), including personal and genealogical data, educational and occupational history and lifestyle factors. Follow up of incident fatal and non-fatal coronary heart disease and stroke events of a subset of the cohort is on-going as our database is being linked with the national healthcare registries and regional and central hospital databases. Events are recorded according to the International Classification of Diseases (ICD-10). All subjects provided written informed consent prior to participation and the approval for the study was granted by the Ethics Review Committee on Human Research at the University of Tartu (5). www.biobank.ee



FINRISK

FINRISK: The FINRISK study is a series of population-based cardiovascular risk factor surveys carried out every five years in five (or six in 2002) districts of Finland, including North Karelia, Northern Savo (former Kuopio), Southwestern Finland, Oulu Province, Lapland province (in 2002 only) and the region of Helsinki and Vantaa. A stratified random sample was drawn for each survey from the national population register, the age-range was 25-74 years. All individuals enrolled in the study received a physical examination, a self-administered questionnaire, and a blood sample was drawn. In 1997, altogether 11,500 individuals were invited and 8,444 (73%) participated in the clinical examination. Approximately 8,000 individuals participated in 2002 and 6,000 in 2007. During follow-up the National Hospital Discharge Register, the National Causes of Death Register and the National Drug Reimbursement Register were used to identify endpoints. At the moment, the follow-up extends until Dec. 31st, 2010, i.e., 14 years for the FINRISK 1997 cohort. The Coordinating Ethics Committee of the Helsinki and Uusimaa Hospital District approved the study, which followed the declaration of Helsinki. All subjects gave written informed consent. http://www.thl.fi/publications/morgam/cohorts/full/finland/fin-fina.htm



GHS

Gutenberg Health Study (GHS): Gutenberg Health Study (GHS): The Gutenberg Health Study (GHS) is designed as a community-based, prospective, observational, single-center cohort study in the Rhine-Main area of Western Germany (6). The sample was drawn randomly from the governmental local registry offices in the city of Mainz and the district of Mainz-Bingen. The sample was stratified 1:1 for sex and residence (urban and rural) and in equal strata for decades of age. Individuals between 35 and 74 years of age were enrolled. Exclusion criteria were insufficient knowledge of the German language and physical or psychological inability to participate in the examinations at the study centre. Baseline examination of 15,000 study participants was performed between 2007 and 2012. A 2.5 year follow-up conducted as a telephone interview started in 2009. Since 2012, the 5-year follow up has been achieved through record linkage, including a second visit at the study centre with extensive medical examination and re-sampling of the biomaterial which is ongoing. http://www.gutenberghealthstudy.org/



Glostrup

Glostrup Study: The Glostrup cohorts are five prospective population based cohorts from 11 municipalities from urban Glostrup of Copenhagen, Denmark. Random sampling based on the national population register, stratified by sex and year of birth was used for cohorts 1, 2 and 3. Cohort 1 consists of men and women aged 30-60 years having two repeated measurements of risk factors and biomarkers. Round 1 of cohort 1 was collected in 1982-1984 (N=3,785) and re-examined in 1987-1988 (Round 2, N=3,000) and 1993-1994 (Round 3, N=2656) (7). Cohort 2 (N=1,504) was examined in 1986-1987 and cohort 3 (N=1,624) was examined in 1991-1992. Inter 99 cohort sampled 6784 men and women in 1999. Health 2006 sampled 4200 men and women from 2006-2008. Follow up is achieved through linkage to the National Cause of Death Register and National Hospital Discharge Register, with endpoint diagnosis based on MORGAM criteria and validation described in 8, 9, 10. Follow up for the cohorts 1, 2, and 3 is completed to December 31st 2010. http://www.thl.fi/publications/morgam/cohorts/full/denmark/den-gloa.htm



HAPIEE

Health, Alcohol and Psychosocial factors in Eastern Europe (HAPIEE): The HAPIEE study comprises four prospective urban population based cohorts from Eastern Europe, including Novosibirsk (Russia), Krakow (Poland), Kaunas (Lithuania) and 7 cities of the Czech Republic (11). Each cohort recruited a random sample of men and women aged 45-69 years at baseline in 2002-05 (2006-08 in Lithuania), stratified by sex and 5-year age group. Participants were selected from population registers (electoral roll list in Russia). Participants completed extensive questionnaire, underwent examination in clinic and provided a blood sample. The sample size (response rates) were 9,360 (61%) in Russia; 10,728 (61%) in Poland; 7,161 (61%) in Lithuania; and 8,857 (55%) in the Czech Republic. Deaths in the cohorts were identified by linkages with national or regional death registers. Non-fatal cardiovascular events were identified via linkage with hospitalisation registers, MONICA registers and by repeated postal follow-up questionnaires validated against GP and hospital records. Follow-up is completed to 2011 for Czech Republic and Lithuania, to 2010 for Russia and to 2009 for Poland. http://www.ucl.ac.uk/easteurope/hapiee.html



KORA

Kooperative Gesundheitsforschung in der Region Augsburg (KORA): The WHO Multinational Monitoring of Trends and Determinants in Cardiovascular Diseases (MONICA)/ Cooperative Health Research in the Region of Augsburg (KORA) cohorts were randomly selected from representative sample surveys from the city of Augsburg and the less urban Landkreis Augsburg and Landkreis Aichach-Friedberg regions in Bavaria, Southern Germany. List of municipalities and population registers were used as sampling frames for the first and the second stage of two-stage sampling, respectively. The second stage of sampling was stratified by sex and 10-year age group. The Survey 3 (S3) baseline examination (1994-1995) was carried out as part of the WHO MONICA project and consists of 4,480 men and women aged 25-74 with a response rate of 74% (12). The Survey 4 baseline examination (S4) was carried out in 1999-2001 consisting of 3,019 men and women aged 25-74 who were re-examined with repeated measurements collected, in 2006-2008 (F4) with a response rate of 72% (13). S4 and F4 studies and morbidity and mortality follow-ups were conducted in the frame of KORA. Coronary events were identified through the MONICA/KORA Augsburg coronary event registry. Coronary deaths were validated by autopsy reports, death certificates, chart review from the last treating physician. Cases with self-reported incident diabetes were validated by the treating physician and medical records documenting use of antidiabetic medication. Self-reported cases of incident stroke were validated by medical records. Mortality follow-up until 2009 was conducted through national death registers. http://www.thl.fi/publications/morgam/cohorts/full/germany/ger-auga.htm



Moli-Sani

Moli-Sani Project: The cohort of the Moli-Sani Project was recruited in the Molise region from city hall registries by a multistage sampling. First, townships were sampled in major areas by cluster sampling; then, within each township, participants aged 35 years or over were selected by simple random sampling. Exclusion criteria were pregnancy at the time of recruitment, lack of in understanding, current multiple trauma or coma, or refusal to sign the informed consent. A total of 24,325 men (47%) and women (53%) over the age of 35 were examined at baseline from 2005 to 2010. Participation was 70%. The cohort was followed-up for a median of 4.2 years (maximum 6.5 years) at December 2011 and will be followed-up every 5 years (14). Follow up is achieved through record linkage to national mortality registries and hospital discharge registers, validation of events was achieved through hospital record linkage and doctors medical records using updated MORGAM criteria. http://www.moli-sani.org/



MONICA Brianza

MONICA Brianza Study: The MONICA-Brianza Cohort Study is a prospective observational study of three cohorts of 25-64 years old residents in Brianza, a highly-industrialized area located between Milan and the Swiss border, Northern Italy. Gender- and 10-year age stratified samples were randomly drawn in 1986, 1990 and 1993, and cardiovascular risk factors were investigated at baseline following the procedures of the WHO MONICA Project (21). The overall participation rate was 69%. For all subjects whole blood and serum samples were stored in a biobank. The protocol was approved by the Monza Hospital Ethical Committee. Baseline examinations were carried out in 1986-87 for cohort 1 of N=1,659 response rate was 69%, Cohort 2 was collected in 1989-90 (N=1599), response rate was 67% and cohort 3 in 1993-1994 (N=1674), response rate was 69%. Study participants were enrolled and followed up for first coronary or stroke events, fatal and non-fatal (22), up to the end of 2008, for a median of 15 years. http://www4.uninsubria.it/on-line/home/naviga-per-tema/ricerca-scientifica/centri-di-ricerca/centro-di-ricerca-in-epidemiologia-e-medicina-preventiva-epimed.html



MONICA Catalonia

MONICA-Catalonia Study: The Catalonia Study consists of two cohorts sampled from representative surveys from the central area of Catalonia and part of the metropolitan area of Barcelona, Spain. The first stage drew a random sample of individuals from nine municipalities with probability proportional to population size. In the second stage, a random sample of men and women from the Municipal population registries were used as the sampling frame, from each municipal population register, a random sample stratified by sex and ten-year age groups, 25-64 years, of fixed number was selected. Baseline examinations were carried out in 1986-1988 for cohort 1 (Round 1) of N=2,571, response rate was 74%. Cohort 2 (Round 1) was collected in 1990-1992 (N=2,936), response rate was 67%. Participants were mainly from the Industrial and services economy (17, 18, 19). All subjects gave informed consent. The project was approved by the Institute of Health Studies steering committee. Follow up until 1997 for Cohort 1 and until 1999 for Cohort 2 was achieved through follow up questionnaires and record linkage with MONICA registers, national mortality index register and hospital discharge registers.



MONICA Friuli

MONICA Friuli: The Friuli population cohorts were collected as part of the WHO MONICA surveys. The Friuli area covers three provinces of north-east Italy (Friuli-Venezia-Giulia) recruited using a single stage sampling frame from the official Regional Health Roll stratified by Health Unit (combination of municipalities covering 40,000 inhabitants), sex and 5-year age group. Four cohorts were recruited, the BiomarCaRE project will focus on Cohort 3 collected in 1994 (participation rate, 71%) consisting of men and women aged 25-64 years and cohort 4 collected in 1995-96, (participation rate, 90% consisting of men and women aged 45-64 years. Follow up through registry linkage is available until 1998 collected through the framework of the Progetto Cuore. http://www.cuore.iss.it/eng/assessment/procedures.asp



MONICA Northern Sweden

The Northern Sweden MONICA Study: The Northern Sweden MONICA study covered the two northernmost counties of Sweden, i.e. Norrbotten and Västerbotten with altogether 510,000 inhabitants. Population surveys were performed in 1986, 1990, 1994, 1999, 2004 and 2009, with altogether 10,517 unique participants (20). On the first two occasions, 2,000 persons aged 25 to 64 years were randomly selected, and in the last three surveys, the upper age limit was extended to 74 years and 2,500 individuals were invited. A stratified randomized selection procedure by age and sex (250 persons in each sex/10-year age stratum) has been used. The participation rate was 69-81%. Detailed analyses of non-participants have been performed. In 1999, all people invited to any of the three previous population surveys were re-invited for repeated measurements to be collected. Incident cardiovascular events (myocardial infarction and stroke) occurring in the region between 1985 and 2010 and below the age of 75 were collected and validated according to MONICA criteria by two event registers whose accuracy and validity have been tested against national registers (21). Follow-up is available for all cohorts until December 2011 for mortality and non- fatal coronary, stroke, chronic heart failure, atrial fibrillation, cancer and diabetes events. Coronary and stroke events below the age of 75 validated applying the MONICA diagnostic criteria, and diabetes according to careful case review (22). http://www9.umu.se/phmed/medicin/monica/index.php?content=startsida, http://www.thl.fi/publications/morgam/cohorts/full/sweden/swe-nswa.htm



PRIME

Prospective Epidemiological Study of Myocardial Infarction (PRIME) Study: The PRIME study examined the classic and putative cardiovascular risk factors to explain the large difference in heart disease incidence between Ireland and France (23). The study includes four cohorts of men aged 50-59; from Belfast, Northern Ireland (N=2,745) and Lille (N=2,633), Toulouse (N=2,610) and Strasbourg (N=2,612) in France. Baseline examinations took place in 1990-1993 and targeted cohorts which had broadly similar social class structures to the background population, initially sampling from industries and various employment groups, employment groups with more than 10% of their workforce of foreign origin were excluded. Follow up until 2004 (Toulouse, Strasbourg and Lille) and until 2012 (Belfast) was achieved through annual follow up questionnaires with verification against national death registers, medical records, hospital discharge diagnoses. Endpoints were validated by expert medical committee. http://www.thl.fi/publications/morgam/cohorts/full/uk/unk-bela.htm; http://www.thl.fi/publications/morgam/cohorts/full/france/fra-lila.htm; http://www.thl.fi/publications/morgam/cohorts/full/france/fra-stra.htm; http://www.thl.fi/publications/morgam/cohorts/full/france/fra-toua.htm



SHHEC

Scottish Heart Health Extended Cohort (SHHEC): This consists of two overlapping studies which share a common protocol and methods: the Scottish Heart Health Study randomly recruited men and women aged 40-59 across 22 Scottish districts in 1984-1987; Scottish MONICA similarly recruited men and women aged 25-64 in Edinburgh and North Glasgow in 1986, and in North Glasgow again in 1989, 1992 (to 74), and in 1995 as part of the WHO MONICA Project. They are now combined as one cohort, although length of follow-up, currently to the end of 2009, inevitably varies in the different components. Follow up is achieved through flagging for death certificates at the National Health Service Death Register and through the Scottish Record Linkage scheme for deaths and hospital discharge records run by Information Services Scotland, which works on probability matching (24). These diagnoses are no longer validated from case notes now that endpoint numbers run into thousands as the cohort ages, but they are allocated to MORGAM categories. Risk factor and endpoint data were used to produce the ASSIGN cardiovascular risk score (25). See. http://www.thl.fi/publications/morgam/cohorts/full/uk/unk-sco.htm



SHIP

Study of Health in Pomerania (SHIP): The SHIP study is an established population-based project conducted in Northeast Germany. The study aims to assess prevalence and incidence of common risk factors, subclinical disorders and clinical diseases and to investigate associations and interactions among them using comprehensive medical assessments (26). The first SHIP cohort was recruited between 1997 and 2001 and included 4,308 individuals at baseline (SHIP-0, 20-70 years, response 68.8%), 3,300 after five years (SHIP-1) and 2,333 after 11 years (SHIP-2). In parallel to SHIP-2, baseline examinations of a second, independent cohort (SHIP-TREND) were conducted in 4,420 participants (20-79 years, response 50.3%). SHIP is one of the population-based projects with very comprehensive examinations including interviews, cardio-metabolic ultrasound exams, cardiopulmonary exercise tests and whole-body magnetic resonance imaging in a general population setting. In addition to the examination follow-ups, information on fatal and non-fatal disease is collected on a regular basis. Mortality follow-ups are conducted semi-annually by record linkage with data bases of the regional population registry. Causes of death are defined from the official death documents provided by regional health authorities. Active follow-ups for non-fatal diseases are performed biannually and by interviews during follow-up examinations every five years. Self-reported information is validated by GP's and using databases of the regional Association of SHI Physicians. http://www.medizin.uni-greifswald.de/cm/fv/ship.html; http://www.medizin.uni-greifswald.de/cm/fv/ship.html



MATISS

The Rome Study (Malattie Aterosclerotiche Istituto Superiore di Sanità (MATISS), (Italy MONICA)): The MATISS study started in 1984 as DiSCo - DIstretto Sezze controllo COmunitario - designed as demonstration project of non-communicable diseases in Central Italy. Four municipalities were involved, three at community treatment and one at control. Baseline (1984) and 4-year examinations were used to evaluate in a random sample of the general population community treatment and compared with control area (27). The project followed as prospective, observational study (MATISS). In 1993-96 the cohorts were re-examined (2,519 persons) and a new random sample, stratified by age and sex, was enrolled from the residence registry (1,970 persons examined, participation rate 60%). Follow-up is available for all cohorts until December 2004 for mortality and non- fatal coronary and stroke events, validated applying the MONICA diagnostic criteria.



Tromsø

The Tromsø Study: The Tromsø Study is a prospective repeated population-based health survey of men and women aged 20-97 years in Northern Norway (28). Specific age groups in the municipality were invited to the different surveys and over time this enabled collection of repeated risk factor measurements in many subjects. The 3rd Tromsø Study survey (Tromsø) was carried out in 1986-87 and those invited were all men in the 20-61 age group, all women in the 20-56 age group, a randomly selected 10% sample from the 12-19 age group (born 1967-1974) and a subsample who were included in a family intervention study. A total of 21,826 participated, 75% of the invited. Of these, data on all men and women aged 20-59 years will be included in the BiomarCaRE study (n= 20,300), including blood samples from Tromsø 3 and also from the subsequent Tromsø 4 survey (participation rate 77%, n=27,158) which contains repeated measurements from Tromsø 3. The cohort is being followed up with registration of incident myocardial infarction, stroke (ischemic, hemorrhagic, subarachnoid haemorrhage and unclassifiable), diabetes, atrial fibrillation and cause-specific death. Cases of incident events were identified by linkage to the diagnosis registry at the University Hospital of North Norway (the only hospital in the region) and to the National Causes of Death Registry. Validation of hospitalized and out-of hospital events was performed by an independent endpoint committee and based on data from hospital and out-of hospital journals, autopsy records, and death certificates. Slightly modified World Health Organization MONICA/MORGAM criteria for myocardial infarction (29) and stroke (30) were used. Follow-up is completed to December 31st 2010. http://tromsoundersokelsen.uit.no/tromso/

Disease Cohorts

AtheroGene

AtheroGene: The AtheroGene study was conducted at the Department of Medicine II of the University Medical Center Mainz and the Federal Armed Forces Central Hospital Koblenz in Germany from 1996 to 2004 (31). The major goal of the AtheroGene study was to assess risk prediction across a wide range of coronary artery disease phenotypes with particular emphasis on the role of genetics. The major endpoint in this study was cardiovascular death and non-fatal myocardial infarction among other cardiovascular outcomes. Inclusion criteria for this study were prevalent coronary artery disease with angiographical diagnosis of a 30% or higher stenosis in a major coronary artery. Exclusion criteria were evidence of hemodynamically significant valvular heart disease, surgery or trauma within the previous month, known cardiomyopathy, malignancies, febrile conditions, chronic inflammatory diseases, renal failure (increased creatinine >2.1 mg/dL) or use of oral anticoagulant therapy within the previous four weeks. Patients presenting with solely elevated C-reactive protein concentrations were not excluded from the study cohort. Fasting blood was drawn prior to catheterization in the cath lab and processed immediately.

APACE

Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study: Consecutive patients who presented to the emergency department with symptoms suggestive of AMI between April 2006 and June 2009 were enrolled in this prospective, international, multi-center study as described previously (32). Blood samples were collected in serum or EDTA plasma tubes at the time of presentation and additional samples were obtained 1, 2, 3, and 6 hours after presentation. Samples were centrifuged and aliquots were stored at -80°C. The study was approved by the local ethics committee and each patient gave written informed consent. http://www.dyspnea.ch/apace.htm



KAROLA

Langzeiterfolge der Kardiologischen Anschlussheilbehandlung (KAROLA): KAROLA is an observational, prospective cohort study in which 1,206 patients with coronary heart disease (CHD) aged 30-70 years participating in an in-hospital rehabilitation program between January 1999 and May 2000 in two co-operating clinics (Schwabenland-Klinik, Isny and Klinik am Südpark, Bad Nauheim, Germany) were enrolled. Only patients who were admitted within 3 months after their first acute event or coronary artery revascularization were included. Baseline data included detailed information from medical records, medical exams and patient questionnaires. An active follow-up has been conducted 1, 3 and 4.5, 6, 8, 10 and 13 years later (33, 34). Beside life style factors, quality of life and other patient reported information obtained by contacting the patient, the occurrence of secondary cardiovascular disease events was evaluated by contacting the primary care physicians. If a subject died during follow-up, the death certificate was obtained from local Public Health departments and the main cause of death was coded according to the International Classification of Diseases. Follow-up is ongoing. http://www.dkfz.de/de/klinepi/Projekte/karola-studie.htm



stenoCardia

Study for evaluation of newly onset chest pain and rapid diagnosis of myocardial necrosis (stenoCardia): Patients with acute chest pain presenting consecutively at the chest pain unit of the Johannes Gutenberg-University Medical Centre Mainz between January 2007 and December 2008 were enrolled in this all-comers prospective biomarker assessment registry (35, as described earlier (36). Blood samples were obtained on admission and after 3 and 6 hours. Routine laboratory parameters including C-reactive protein were measured immediately after blood withdrawal by standardized methods. Additionally, EDTA plasma and serum samples were collected at each time point, centrifuged, aliquoted and stored at -80°C. The study was approved by the local ethics committees. Participation was voluntary; each patient gave written, informed consent.



ACS

UCSC-ACS: prospective cohort under enrollment at the Cardiology Institute of the Catholic University of Rome: The major goal of the UCSC-ACS study is to provide a large and contemporary cohort of patients hospitalized for acute ischemic heart disease, with a prevalence of NSTEMI-UA. The subjects are treated with invasive procedures or cardiac surgery, unless contraindicated and cover a large spectrum of ages and conditions. All patients will be followed for at least 6 months and up to one year for all relevant events (new hospitalization for any cause, ACS, heart failure or death) will be recorded. Exclusion criteria are severe comorbidities limiting life expectancy at less than one year, active cancer, sepsis or chronic and acute inflammatory diseases. Fasting blood is taken within 12 hours from hospital admission for UA/NSTEMI and 30 min for STEMI, which is divided into 100 microliter aliquots and immediately stored at -80 degrees (37). www.rm.unicatt.it

Clinical Trials

IBIS-2

Integrated Biomarker and Imaging Study-2 (IBIS-2): IBIS-2 (Study 026) was a multi-center, randomized, double blind, placebo-controlled, parallel group study designed to examine the effects of once daily Darapladib Enteric Coated Tablet 160 mg (n = 172) on intermediate cardiovascular endpoints compared to placebo (n = 151) (38). The study evaluated intravascular ultrasound (IVUS)-based imaging parameters, circulating biomarkers, endothelial function, safety and tolerability over the 1-year treatment duration in subjects from 10 countries in Europe (Denmark, Netherlands, Germany, Switzerland, Poland, Austria, Spain, Norway, Belgium, Czech Republic). By design, the study included approximately 50% of subjects with acute coronary syndrome (ACS), either ST-elevation Myocardial Infarction (STEMI) or Non-STEMI, or non-ACS patients with coronary heart disease. The mean age of subjects was 58 years (range, 33 to 82 years), and the majority of participants were white (98%) and male (82%).



LIPID

The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study: the LIPID Study was a randomised, double-blind, placebo-controlled parallel group study conducted in 9,014 patients recruited from 87 centres in Australia and New Zealand (39). It was designed to examine the effects of 40mg pravastatin o.d on cardiovascular outcomes in patients who were stable after myocardial infarction or hospitalisation for unstable angina 3-36 months previously. Patients had baseline total cholesterol of 4.0-7.0mmol/L and triglycerides <5mmol/L and at baseline a high percentage received other evidence-based therapies for coronary heart disease. Over a mean follow-up of 6.0 years there was a highly significant reduction in coronary heart disease mortality, the primary study endpoint, total mortality and all other prespecified cardiovascular end-points. http://www.ctc.usyd.edu.au/our-research/clinical-trials/diabetes-and-cardiovascular/lipid.aspx



JUPITER

The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial: JUPITER is a completed, randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg daily in the prevention of cardiovascular disease. Men who were at least 50 years old and women at least 60 years old were eligible for the trial if they did not have preexisting cardiovascular disease or diabetes, and had a low density lipoprotein cholesterol < 130 mg/dL and C-reactive protein ≥ 2.0 mg/L. JUPITER enrolled and randomized 17,802 subjects who were then followed for a median of 1.9 years (40, 41). http://www.brighamandwomens.org/research/depts/medicine/preventive_medicine/research_areas/jupiter_trial.aspx



TRANSCEND

The Telmisartan Randomised Assessment Study in ACE intolerant subjects with cardiovascular disease (TRANSCEND) Trial: In the TRANSCEND Trial, eligible patients were entered into a single blind run-in involving placebo daily for a week followed by 2 weeks of telmisartan 80 mg. At the end of this run-in period, patients were randomised in a one to one ratio by use of a central automated randomisation system to receive telmisartan (80 mg/day) or placebo. Patients were assessed at follow-up visits scheduled at 6 weeks and 6 months, and then every 6 months The aim was to investigate whether an angiotensin receptor blocker—telmisartan—when given long term, reduces cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure in patients with cardiovascular disease or high-risk diabetes and without heart failure, who are intolerant of ACE inhibitors, compared with placebo (42). http://www.trialresultscenter.org/study8595-TRANSCEND.htm



WHS

The Women's Health (WHS) Study: The WHS is a completed, randomized, double-blind, placebo controlled 2x2 factorial trial of vitamin E and aspirin in the prevention of cardiovascular disease and cancer in nearly 39,876 initially healthy female health professionals aged 45 years and older in the United States (43, 44). Enrolment began in 1993, and the randomized trial portion of the study was completed in March 2004. Participants were invited to continue in an observational follow up cohort. In total, 28,345 women provided blood samples at baseline for analysis. http://whs.bwh.harvard.edu/publications2.html