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Active, Not Recruiting

NCT Number: NCT03192410

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Behavior Cognition Disorders Cognitive Decline Cognitive Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Kidney Function Mental Disorders Mental Well-being Metabolic Diseases Mortality Myocardial Infarction Myocardial Ischemia Necrosis Neurocognitive Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Type 2 Diabetes Mellitus Vascular Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, 6700 AA, Netherlands

About this study

Details are reported in publications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intake

Behavioral

Intake of nutrients, foods, food groups, beverages; dietary patterns.

Lifestyle factors

Behavioral

Physical activity; smoking; alcohol use; educational level.

Blood biomarkers

Biological

Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.

Health

Biological

Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)

DNA

Genetic

SNPs (GWAS)

Mental well-being

Biological

Cognitive function; dispositional optimism; depression.

Primary outcomes

  1. Cardiovascular mortality

    Time frame: From entry into the study (baseline: 2002-2006) through study completion

    Death from cardiovascular disease, obtained from causes of death register of Statistics Netherlands

  2. All-cause mortality

    Time frame: From entry into the study (baseline: 2002-2006) through study completion

    Vital status obtained from municipal population registers in the Netherlands

  3. Major cardiovascular events

    Time frame: 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 outcomes

  1. Coronary heart disease

    Time frame: 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

  2. Stroke

    Time frame: 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

  3. Non-cardiovascular mortality

    Time frame: 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

  4. Type 2 diabetes

    Time frame: 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

  5. Kidney function

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in serum cystatin C-based estimated glomerular filtration rate

  6. Cognitive function

    Time frame: 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 outcomes

  1. Depression

    Time frame: After 40 months of follow-up

    Score on 15-item Geriatric Depression Scale

  2. Dispositional optimism

    Time frame: After 40 months of follow-up

    Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R)

  3. Body weight

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in body weight, assessed by trained research nurses

  4. Blood pressure

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in office blood pressure, assessed by trained research nurses

  5. Blood lipids

    Time frame: 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

  6. Glucose metabolism

    Time frame: 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

  7. DNA genotype

    Time frame: At baseline (2002-2006)

    DNA genotype, assessed by Global Screening Array (Illumina, Inc.)

  8. Biochemical markers of Inflammation

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in blood biomarkers of inflammation, assessed by MesoScale assays

  9. Biochemical markers of endothelial function

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in blood biomarkers of endothelial function, assessed by MesoScale assays

  10. Biomarkers of cardiac function

    Time frame: 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

  11. Biomarkers of kidney function

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in blood biomarkers of kidney function, assessed by immunoassay

  12. Prostate-specific antigen (PSA)

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in blood total PSA concentration, assessed by immunometric assay

  13. Testosterone

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in serum testosterone concentration, assessed by immunoassay

  14. Circulating fatty acids

    Time frame: From entry into the study (baseline: 2002-2006) until November 2009

    Change in concentration of fatty acids (percent weight) in plasma cholesteryl esters

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Important dates

Study start
2002
Primary completion
2040
Study completion
2040
First posted
Jun 20, 2017
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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