Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date June 10, 2017
First Posted Date June 20, 2017
Last Update Posted Date June 20, 2017
Actual Study Start Date April 2002
Estimated Primary Completion Date January 2040   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 15, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 15, 2017)
  • Depression [ Time Frame: After 40 months of follow-up ]
    Score on 15-item Geriatric Depression Scale
  • Dispositional optimism [ Time Frame: After 40 months of follow-up ]
    Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R)
  • Body weight [ Time Frame: From entry into the study (baseline: 2002-2006) until November 2009 ]
    Change in body weight, assessed by trained research nurses
  • 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
  • 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
  • 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
  • DNA genotype [ Time Frame: At baseline (2002-2006) ]
    DNA genotype, assessed by Global Screening Array (Illumina, Inc.)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Testosterone [ Time Frame: From entry into the study (baseline: 2002-2006) until November 2009 ]
    Change in serum testosterone concentration, assessed by immunoassay
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
Official Title Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
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.
Detailed Description Details are reported in publications.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Cardiovascular Diseases
  • Mortality
  • Type 2 Diabetes Mellitus
  • Cognitive Decline
  • Mental Well-being
  • Kidney Function
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 15, 2017)
4837
Original Actual Enrollment Same as current
Estimated Study Completion Date January 2040
Estimated Primary Completion Date January 2040   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03192410
Other Study ID Numbers Alpha Omega Cohort
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Geleijnse, Wageningen University
Study Sponsor Wageningen University
Collaborators Not Provided
Investigators
Principal Investigator: Johanna M Geleijnse, PhD Wageningen University, Division of Human Nutrition
PRS Account Wageningen University
Verification Date June 2017