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

June 15, 2017 updated by: Geleijnse, Wageningen University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Details are reported in publications.

Study Type

Observational

Enrollment (Actual)

4837

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6700 AA
        • Wageningen University, Division of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

4837 patients (78% male) with a history of myocardial infarction up to 10 y before entry into the study, recruited from 32 hospitals in the Netherlands.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From entry into the study (baseline: 2002-2006) through study completion
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
From entry into the study (baseline: 2002-2006) through study completion
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
From entry into the study (baseline: 2002-2006) until November 2009

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From entry into the study (baseline: 2002-2006) through study completion
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
From entry into the study (baseline: 2002-2006) through study completion
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
From entry into the study (baseline: 2002-2006) through study completion
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: After 40 months of follow-up
Score on 15-item Geriatric Depression Scale
After 40 months of follow-up
Dispositional optimism
Time Frame: After 40 months of follow-up
Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R)
After 40 months of follow-up
Body weight
Time Frame: From entry into the study (baseline: 2002-2006) until November 2009
Change in body weight, assessed by trained research nurses
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
DNA genotype
Time Frame: At baseline (2002-2006)
DNA genotype, assessed by Global Screening Array (Illumina, Inc.)
At baseline (2002-2006)
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009
Testosterone
Time Frame: From entry into the study (baseline: 2002-2006) until November 2009
Change in serum testosterone concentration, assessed by immunoassay
From entry into the study (baseline: 2002-2006) until November 2009
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
From entry into the study (baseline: 2002-2006) until November 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Investigators

  • Principal Investigator: Johanna M Geleijnse, PhD, Wageningen University, Division of Human Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2002

Primary Completion (Anticipated)

January 1, 2040

Study Completion (Anticipated)

January 1, 2040

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alpha Omega Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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