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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192410
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Geleijnse, Wageningen University

Study Description
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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
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
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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 : April 2002
Estimated Primary Completion Date : January 2040
Estimated Study Completion Date : January 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Intervention Details:
  • Behavioral: Dietary intake
    Intake of nutrients, foods, food groups, beverages; dietary patterns.
  • Behavioral: Lifestyle factors
    Physical activity; smoking; alcohol use; educational level.
  • Biological: Blood biomarkers
    Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.
  • Biological: Health
    Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)
  • Genetic: DNA
    SNPs (GWAS)
  • Biological: Mental well-being
    Cognitive function; dispositional optimism; depression.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Non-fasting venous blood samples were taken in 4785 patients at baseline, in 810 patients after 20 months and in 2503 patients after 40 months of follow-up. DNA has been extracted for genotyping.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192410


Locations
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Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands, 6700 AA
Sponsors and Collaborators
Wageningen University
Investigators
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Principal Investigator: Johanna M Geleijnse, PhD Wageningen University, Division of Human Nutrition
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Geleijnse, Professor of Nutrition and Cardiovascular Disease, Wageningen University
ClinicalTrials.gov Identifier: NCT03192410    
Other Study ID Numbers: Alpha Omega Cohort
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geleijnse, Wageningen University:
myocardial infarction
cardiovascular diseases
mortality
post-myocardial infarction patients
 risk prediction
kidney function
mental well-being
cardiovascular drug treatment
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Diabetes Mellitus, Type 2
Infarction
Cognitive Dysfunction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Vascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders