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

Active, not recruiting

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

• Registration Number: NCT03192410
• Lead Sponsor: Wageningen University

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.

Study Timeline

• Study Start: 2002-04
• Status Verified: 2017-06
• Study First Submitted: 2017-06-10
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Primary Completion: 2040-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4837

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
All-cause mortality	From entry into the study (baseline: 2002-2006) through study completion	Vital status obtained from municipal population registers in the Netherlands

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wageningen University, Division of Human Nutrition; 🇳🇱 Wageningen, Netherlands