Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)

Study Overview
=================
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.

Official Title
-----------------
Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)

Conditions
-----------------
Mortality, Cardiovascular Diseases, Type 2 Diabetes Mellitus, Cognitive Decline, Mental Well-being, Kidney Function

Intervention / Treatment
-----------------
* Behavioral: Dietary intake
* Behavioral: Lifestyle factors
* Biological: Blood biomarkers
* Biological: Health
* Genetic: DNA
* Biological: Mental well-being


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Dietary intake|Intake of nutrients, foods, food groups, beverages; dietary patterns.|
|Behavioral: Lifestyle factors|Physical activity; smoking; alcohol use; educational level.|
|Biological: Blood biomarkers|Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.|
|Biological: Health|Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)|
|Genetic: DNA|SNPs (GWAS)|
|Biological: Mental well-being|Cognitive function; dispositional optimism; depression.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| All-cause mortality | Vital status obtained from municipal population registers in the Netherlands | From entry into the study (baseline: 2002-2006) through study completion | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Kidney function | Change in serum cystatin C-based estimated glomerular filtration rate | From entry into the study (baseline: 2002-2006) until November 2009 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial infarction, cardiovascular diseases, mortality, post-myocardial infarction patients, risk prediction, kidney function, mental well-being, cardiovascular drug treatment