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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Details are reported in publications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2002

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2040

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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