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

Sponsor

Wageningen University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03192410

Collaborator

(none)

4,837

Enrollment

Location

453

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Mortality Type 2 Diabetes Mellitus Cognitive Decline Mental Well-being Kidney Function	Behavioral: Dietary intake Behavioral: Lifestyle factors Biological: Blood biomarkers Biological: Health Genetic: DNA Biological: Mental well-being

Detailed Description

Details are reported in publications.

Study Design

Study Type:

Observational

Actual Enrollment :

4837 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2002

Anticipated Primary Completion Date :

Jan 1, 2040

Anticipated Study Completion Date :

Jan 1, 2040

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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

Other Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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