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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03192410
• Other study ID #: Alpha Omega Cohort
• Status: Active, not recruiting
• Phase: N/A
• First received: June 10, 2017
• Last updated: June 15, 2017
• Start date: April 2002
• Est. completion date: January 2040

Study information

• Verified date: June 2017
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Details are reported in publications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4837
• Est. completion date: January 2040
• Est. primary completion date: January 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Decline
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Infarction
• Kidney Function
• Mental Well-being
• Mortality
• Myocardial Infarction
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Dietary intake
Intake of nutrients, foods, food groups, beverages; dietary patterns.
• Lifestyle factors
Physical activity; smoking; alcohol use; educational level.

Biological:
• Blood biomarkers
Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.
• 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.

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Geleijnse JM, Giltay EJ, Schouten EG, de Goede J, Oude Griep LM, Teitsma-Jansen AM, Katan MB, Kromhout D; Alpha Omega Trial Group. Effect of low doses of n-3 fatty acids on cardiovascular diseases in 4,837 post-myocardial infarction patients: design and baseline characteristics of the Alpha Omega Trial. Am Heart J. 2010 Apr;159(4):539-546.e2. doi: 10.1016/j.ahj.2009.12.033. — View Citation

Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441 — View Citation

Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010 Nov 18;363(21):2015-26. doi: 10.1056/NEJMoa1003603. Epub 2010 Aug 28. — View Citation

Sijtsma FP, Soedamah-Muthu SS, de Goede J, Oude Griep LM, Geleijnse JM, Giltay EJ, de Boer MJ, Jacobs DR Jr, Kromhout D. Healthy eating and lower mortality risk in a large cohort of cardiac patients who received state-of-the-art drug treatment. Am J Clin — View Citation

Soedamah-Muthu SS, Geleijnse JM, Giltay EJ, de Goede J, Oude Griep LM, Waterham E, Teitsma-Jansen AM, Mulder BJ, de Boer MJ, Deckers JW, Zock PL, Kromhout D; for the Alpha Omega Trial Group . Levels and trends in cardiovascular risk factors and drug treat — View Citation

Soedamah-Muthu SS, Geleijnse JM, Giltay EJ, Kromhout D; Alpha Omega Trial Group. Cardiovascular risk factor management of myocardial infarction patients with and without diabetes in the Netherlands between 2002 and 2006: a cross-sectional analysis of base — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Score on 15-item Geriatric Depression Scale	After 40 months of follow-up
Other	Dispositional optimism	Scores on a 4-item questionnaire and the (revised) Life Orientation Test (LOT-R)	After 40 months of follow-up
Other	Body weight	Change in body weight, assessed by trained research nurses	From entry into the study (baseline: 2002-2006) until November 2009
Other	Blood pressure	Change in office blood pressure, assessed by trained research nurses	From entry into the study (baseline: 2002-2006) until November 2009
Other	Blood lipids	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
Other	Glucose metabolism	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
Other	DNA genotype	DNA genotype, assessed by Global Screening Array (Illumina, Inc.)	At baseline (2002-2006)
Other	Biochemical markers of Inflammation	Change in blood biomarkers of inflammation, assessed by MesoScale assays	From entry into the study (baseline: 2002-2006) until November 2009
Other	Biochemical markers of endothelial function	Change in blood biomarkers of endothelial function, assessed by MesoScale assays	From entry into the study (baseline: 2002-2006) until November 2009
Other	Biomarkers of cardiac function	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
Other	Biomarkers of kidney function	Change in blood biomarkers of kidney function, assessed by immunoassay	From entry into the study (baseline: 2002-2006) until November 2009
Other	Prostate-specific antigen (PSA)	Change in blood total PSA concentration, assessed by immunometric assay	From entry into the study (baseline: 2002-2006) until November 2009
Other	Testosterone	Change in serum testosterone concentration, assessed by immunoassay	From entry into the study (baseline: 2002-2006) until November 2009
Other	Circulating fatty acids	Change in concentration of fatty acids (percent weight) in plasma cholesteryl esters	From entry into the study (baseline: 2002-2006) until November 2009
Primary	Cardiovascular mortality	Death from cardiovascular disease, obtained from causes of death register of Statistics Netherlands	From entry into the study (baseline: 2002-2006) through study completion
Primary	All-cause mortality	Vital status obtained from municipal population registers in the Netherlands	From entry into the study (baseline: 2002-2006) through study completion
Primary	Major cardiovascular events	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	Coronary heart disease	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
Secondary	Stroke	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
Secondary	Non-cardiovascular mortality	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
Secondary	Type 2 diabetes	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
Secondary	Kidney function	Change in serum cystatin C-based estimated glomerular filtration rate	From entry into the study (baseline: 2002-2006) until November 2009
Secondary	Cognitive function	Change in global cognitive function, based on Mini Mental State Examination (MMSE) score	From entry into the study (baseline: 2002-2006) until November 2009

External Links

•   Website of the Alpha Omega Trial (experimental phase of Alpha Omega Cohort)