Cardiovascular Diseases Clinical Trial
Official title:
Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
Verified date | June 2017 |
Source | Wageningen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years before enrolment. During the first 40 months of follow-up, patients took part in an experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet, lifestyle and other factors were collected by means of questionnaires. Patients were physically examined by trained research nurses and blood samples were obtained. Follow-up for vital status and cause-specific mortality is ongoing. The trial was approved by a central medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients provided written informed consent.
Status | Active, not recruiting |
Enrollment | 4837 |
Est. completion date | January 2040 |
Est. primary completion date | January 2040 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
The Alpha Omega Cohort is a prospective cohort study. The cohort originated from the Alpha
Omega Trial, a 40-month intervention study of low doses of n-3 fatty acids (in margarine
spreads) and cardiovascular events (NCT00127452). The in/exclusion criteria were defined
for the Alpha Omega Trial. Inclusion criteria: - Men and women - Aged 60 through 80 y - Verified clinically diagnosed myocardial infarction up to 10 y before entry into the study - Written informed consent Exclusion criteria: - Living in a nursing home or other institution - Participation in another scientific study - Habitual margarine intake < 10 g per day - Habitual fish intake > 150 g per day - Habitual alcohol intake > 6 drinks per day - Use of fish oil capsules or other supplements containing omega-3 fatty acids - Presence of cancer with < 1 y of life expectancy - Cognitive impairment, as indicated by the Mini Mental State Examination (score <= 21) - Unintended weight loss > 5 kg in the past year - Lack of facilities for cooled margarine storage at home - Inability or unwillingness to comply with study procedures |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University, Division of Human Nutrition | Wageningen |
Lead Sponsor | Collaborator |
---|---|
Wageningen University |
Netherlands,
Geleijnse JM, Giltay EJ, Schouten EG, de Goede J, Oude Griep LM, Teitsma-Jansen AM, Katan MB, Kromhout D; Alpha Omega Trial Group. Effect of low doses of n-3 fatty acids on cardiovascular diseases in 4,837 post-myocardial infarction patients: design and baseline characteristics of the Alpha Omega Trial. Am Heart J. 2010 Apr;159(4):539-546.e2. doi: 10.1016/j.ahj.2009.12.033. — View Citation
Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441 — View Citation
Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010 Nov 18;363(21):2015-26. doi: 10.1056/NEJMoa1003603. Epub 2010 Aug 28. — View Citation
Sijtsma FP, Soedamah-Muthu SS, de Goede J, Oude Griep LM, Geleijnse JM, Giltay EJ, de Boer MJ, Jacobs DR Jr, Kromhout D. Healthy eating and lower mortality risk in a large cohort of cardiac patients who received state-of-the-art drug treatment. Am J Clin — View Citation
Soedamah-Muthu SS, Geleijnse JM, Giltay EJ, de Goede J, Oude Griep LM, Waterham E, Teitsma-Jansen AM, Mulder BJ, de Boer MJ, Deckers JW, Zock PL, Kromhout D; for the Alpha Omega Trial Group . Levels and trends in cardiovascular risk factors and drug treat — View Citation
Soedamah-Muthu SS, Geleijnse JM, Giltay EJ, Kromhout D; Alpha Omega Trial Group. Cardiovascular risk factor management of myocardial infarction patients with and without diabetes in the Netherlands between 2002 and 2006: a cross-sectional analysis of base — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Depression | Score on 15-item Geriatric Depression Scale | After 40 months of follow-up | |
Other | Dispositional optimism | Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R) | After 40 months of follow-up | |
Other | Body weight | Change in body weight, assessed by trained research nurses | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Blood pressure | Change in office blood pressure, assessed by trained research nurses | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Blood lipids | Change in non-fasting serum total, LDL and HDL cholesterol, assessed by standard laboratory methods | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Glucose metabolism | Change in non-fasting plasma glucose, insulin and HbA1C, assessed by standard laboratory methods | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | DNA genotype | DNA genotype, assessed by Global Screening Array (Illumina, Inc.) | At baseline (2002-2006) | |
Other | Biochemical markers of Inflammation | Change in blood biomarkers of inflammation, assessed by MesoScale assays | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Biochemical markers of endothelial function | Change in blood biomarkers of endothelial function, assessed by MesoScale assays | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Biomarkers of cardiac function | Change in blood biomarkers of cardiac function (e.g, NT-proBNP, troponin), assessed by chemiluminescence | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Biomarkers of kidney function | Change in blood biomarkers of kidney function, assessed by immunoassay | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Prostate-specific antigen (PSA) | Change in blood total PSA concentration, assessed by immunometric assay | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Testosterone | Change in serum testosterone concentration, assessed by immunoassay | From entry into the study (baseline: 2002-2006) until November 2009 | |
Other | Circulating fatty acids | Change in concentration of fatty acids (percent weight) in plasma cholesteryl esters | From entry into the study (baseline: 2002-2006) until November 2009 | |
Primary | Cardiovascular mortality | Death from cardiovascular disease, obtained from causes of death register of Statistics Netherlands | From entry into the study (baseline: 2002-2006) through study completion | |
Primary | All-cause mortality | Vital status obtained from municipal population registers in the Netherlands | From entry into the study (baseline: 2002-2006) through study completion | |
Primary | Major cardiovascular events | Incidence of fatal and nonfatal cardiovascular events and hospitalisations for cardiac interventions, based on verified information from GP records, hospital records and mortality registers | From entry into the study (baseline: 2002-2006) until November 2009 | |
Secondary | Coronary heart disease | Incidence of fatal and non-fatal coronary heart disease, based on verified information from GP records, hospital records and mortality registers | From entry into the study (baseline: 2002-2006) through study completion | |
Secondary | Stroke | Incidence of fatal and non-fatal stroke, based on verified information from GP records, hospital records and mortality registers | From entry into the study (baseline: 2002-2006) through study completion | |
Secondary | Non-cardiovascular mortality | Death from cancer or other non-cardiovascular causes, obtained from causes of death register of Statistics Netherlands | From entry into the study (baseline: 2002-2006) through study completion | |
Secondary | Type 2 diabetes | Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, use of antidiabetic drugs, or elevated blood glucose | From entry into the study (baseline: 2002-2006) until November 2009 | |
Secondary | Kidney function | Change in serum cystatin C-based estimated glomerular filtration rate | From entry into the study (baseline: 2002-2006) until November 2009 | |
Secondary | Cognitive function | Change in global cognitive function, based on Mini Mental State Examination (MMSE) score | From entry into the study (baseline: 2002-2006) until November 2009 |
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