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

Wageningen University

Status: Active, not recruiting

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

Treatments: Genetic: DNA; Behavioral: Dietary intake; Biological: Blood biomarkers; Behavioral: Lifestyle factors; Biological: Health; Biological: Mental well-being

Study type: Observational

Funder types: Other

Identifiers

NCT03192410

Alpha Omega Cohort

Details and patient eligibility

About

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.

Full description

Details are reported in publications.

Enrollment: 4,837 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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