Cardiovascular Diseases, Mortality, Type 2 Diabetes Mellitus, Cognitive Decline, Mental Well-being, Kidney Function
Conditions
Keywords
myocardial infarction, cardiovascular diseases, mortality, post-myocardial infarction patients, risk prediction, kidney function, mental well-being, cardiovascular drug treatment
Brief summary
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.
Detailed description
Details are reported in publications.
Interventions
BEHAVIORALDietary intake
Intake of nutrients, foods, food groups, beverages; dietary patterns.
BEHAVIORALLifestyle factors
Physical activity; smoking; alcohol use; educational level.
BIOLOGICALBlood biomarkers
Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.
BIOLOGICALHealth
Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)
GENETICDNA
SNPs (GWAS)
BIOLOGICALMental well-being
Cognitive function; dispositional optimism; depression.
Sponsors
Wageningen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | From entry into the study (baseline: 2002-2006) through study completion | Death from cardiovascular disease, obtained from causes of death register of Statistics Netherlands |
| All-cause mortality | From entry into the study (baseline: 2002-2006) through study completion | Vital status obtained from municipal population registers in the Netherlands |
| Major cardiovascular events | From entry into the study (baseline: 2002-2006) until November 2009 | Incidence of fatal and nonfatal cardiovascular events and hospitalisations for cardiac interventions, based on verified information from GP records, hospital records and mortality registers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | From entry into the study (baseline: 2002-2006) through study completion | Incidence of fatal and non-fatal stroke, based on verified information from GP records, hospital records and mortality registers |
| Non-cardiovascular mortality | From entry into the study (baseline: 2002-2006) through study completion | Death from cancer or other non-cardiovascular causes, obtained from causes of death register of Statistics Netherlands |
| Type 2 diabetes | From entry into the study (baseline: 2002-2006) until November 2009 | Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, use of antidiabetic drugs, or elevated blood glucose |
| Kidney function | From entry into the study (baseline: 2002-2006) until November 2009 | Change in serum cystatin C-based estimated glomerular filtration rate |
| Cognitive function | From entry into the study (baseline: 2002-2006) until November 2009 | Change in global cognitive function, based on Mini Mental State Examination (MMSE) score |
| Coronary heart disease | From entry into the study (baseline: 2002-2006) through study completion | Incidence of fatal and non-fatal coronary heart disease, based on verified information from GP records, hospital records and mortality registers |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical markers of endothelial function | From entry into the study (baseline: 2002-2006) until November 2009 | Change in blood biomarkers of endothelial function, assessed by MesoScale assays |
| Biomarkers of cardiac function | From entry into the study (baseline: 2002-2006) until November 2009 | Change in blood biomarkers of cardiac function (e.g, NT-proBNP, troponin), assessed by chemiluminescence |
| Biomarkers of kidney function | From entry into the study (baseline: 2002-2006) until November 2009 | Change in blood biomarkers of kidney function, assessed by immunoassay |
| Prostate-specific antigen (PSA) | From entry into the study (baseline: 2002-2006) until November 2009 | Change in blood total PSA concentration, assessed by immunometric assay |
| Testosterone | From entry into the study (baseline: 2002-2006) until November 2009 | Change in serum testosterone concentration, assessed by immunoassay |
| Circulating fatty acids | From entry into the study (baseline: 2002-2006) until November 2009 | Change in concentration of fatty acids (percent weight) in plasma cholesteryl esters |
| Depression | After 40 months of follow-up | Score on 15-item Geriatric Depression Scale |
| Dispositional optimism | After 40 months of follow-up | Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R) |
| Body weight | From entry into the study (baseline: 2002-2006) until November 2009 | Change in body weight, assessed by trained research nurses |
| Blood pressure | From entry into the study (baseline: 2002-2006) until November 2009 | Change in office blood pressure, assessed by trained research nurses |
| Blood lipids | From entry into the study (baseline: 2002-2006) until November 2009 | Change in non-fasting serum total, LDL and HDL cholesterol, assessed by standard laboratory methods |
| Glucose metabolism | From entry into the study (baseline: 2002-2006) until November 2009 | Change in non-fasting plasma glucose, insulin and HbA1C, assessed by standard laboratory methods |
| DNA genotype | At baseline (2002-2006) | DNA genotype, assessed by Global Screening Array (Illumina, Inc.) |
| Biochemical markers of Inflammation | From entry into the study (baseline: 2002-2006) until November 2009 | Change in blood biomarkers of inflammation, assessed by MesoScale assays |
Countries
Netherlands
Outcome results
None listed