Cardiovascular DiseasesNCT03192410
Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
An observational study of Cardiovascular Diseases and Mortality, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Mortality, Type 2 Diabetes Mellitus
- What is being tested?
- Dietary intake, Lifestyle factors and Blood biomarkers
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,837 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2002to Jan 2040
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, 6700 AA
About this study
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.
Read the detailed description
Details are reported in publications.
- Conditions
- Cardiovascular Diseases, Mortality, Type 2 Diabetes Mellitus, Cognitive Decline, Mental Well-being, Kidney Function
- Being tested
- Dietary intake, Lifestyle factors, Blood biomarkers, Health, DNA
- Keywords
- myocardial infarction, cardiovascular diseases, mortality, post-myocardial infarction patients, risk prediction, kidney function, mental well-being, cardiovascular drug treatment
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Cognitive Dysfunction, Psychological Well-Being, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intakeBehavioural
Intake of nutrients, foods, food groups, beverages; dietary patterns.
Lifestyle factorsBehavioural
Physical activity; smoking; alcohol use; educational level.
Blood biomarkersBiological
Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.
HealthBiological
Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)
DNAGenetic
SNPs (GWAS)
Mental well-beingBiological
Cognitive function; dispositional optimism; depression.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Death from cardiovascular disease, obtained from causes of death register of Statistics Netherlands
Measured: From entry into the study (baseline: 2002-2006) through study completion
All-cause mortality
Vital status obtained from municipal population registers in the Netherlands
Measured: From entry into the study (baseline: 2002-2006) through study completion
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
Measured: From entry into the study (baseline: 2002-2006) until November 2009
Secondary outcomes (6)
Coronary heart disease
Incidence of fatal and non-fatal coronary heart disease, based on verified information from GP records, hospital records and mortality registers
Measured: From entry into the study (baseline: 2002-2006) through study completion
Stroke
Incidence of fatal and non-fatal stroke, based on verified information from GP records, hospital records and mortality registers
Measured: From entry into the study (baseline: 2002-2006) through study completion
Non-cardiovascular mortality
Death from cancer or other non-cardiovascular causes, obtained from causes of death register of Statistics Netherlands
Measured: From entry into the study (baseline: 2002-2006) through study completion
Type 2 diabetes
Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, use of antidiabetic drugs, or elevated blood glucose
Measured: From entry into the study (baseline: 2002-2006) until November 2009
Kidney function
Change in serum cystatin C-based estimated glomerular filtration rate
Measured: From entry into the study (baseline: 2002-2006) until November 2009
Cognitive function
Change in global cognitive function, based on Mini Mental State Examination (MMSE) score
Measured: From entry into the study (baseline: 2002-2006) until November 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study startApr 2002
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Geleijnse, Wageningen University
- Investigators
- Johanna M Geleijnse, PhD, Principal investigator, Wageningen University, Division of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192410
- Sponsor's protocol ID
- Alpha Omega Cohort
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2017
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20362710Kromhout 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.
PubMed 20929341Sijtsma 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 Nutr. 2015 Dec;102(6):1527-33. doi: 10.3945/ajcn.115.112276. Epub 2015 Oct 21.
PubMed 26490494Hoogeveen 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.10441013. Epub 2014 Aug 7.
PubMed 25104273Soedamah-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 baseline data. BMJ Open. 2012 Oct 31;2(6):e001360. doi: 10.1136/bmjopen-2012-001360. Print 2012.
PubMed 23117562Soedamah-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 treatment in 4837 elderly Dutch myocardial infarction patients between 2002 and 2006. Neth Heart J. 2012 Feb 8;20(3):102-9. doi: 10.1007/s12471-012-0248-z. Online ahead of print.
PubMed 22314614Evers I, Cruijsen E, Kornaat I, Winkels RM, Busstra MC, Geleijnse JM. Dietary magnesium and risk of cardiovascular and all-cause mortality after myocardial infarction: A prospective analysis in the Alpha Omega Cohort. Front Cardiovasc Med. 2022 Aug 12;9:936772. doi: 10.3389/fcvm.2022.936772. eCollection 2022.
PubMed 36035961Cruijsen E, Indyk IM, Simon AWE, Busstra MC, Geleijnse JM. Potato Consumption and Risk of Cardiovascular Mortality and Type 2 Diabetes After Myocardial Infarction: A Prospective Analysis in the Alpha Omega Cohort. Front Nutr. 2022 Jan 27;8:813851. doi: 10.3389/fnut.2021.813851. eCollection 2021.
PubMed 35155529Pertiwi K, Kupers LK, de Goede J, Zock PL, Kromhout D, Geleijnse JM. Dietary and Circulating Long-Chain Omega-3 Polyunsaturated Fatty Acids and Mortality Risk After Myocardial Infarction: A Long-Term Follow-Up of the Alpha Omega Cohort. J Am Heart Assoc. 2021 Dec 7;10(23):e022617. doi: 10.1161/JAHA.121.022617. Epub 2021 Nov 30.
PubMed 34845924Cruijsen E, de Ruiter AJ, Kupers LK, Busstra MC, Geleijnse JM. Alcohol intake and long-term mortality risk after myocardial infarction in the Alpha Omega Cohort. Am J Clin Nutr. 2022 Mar 4;115(3):633-642. doi: 10.1093/ajcn/nqab366.
PubMed 34734223Cruijsen E, Jacobo Cejudo MG, Kupers LK, Busstra MC, Geleijnse JM. Dairy consumption and mortality after myocardial infarction: a prospective analysis in the Alpha Omega Cohort. Am J Clin Nutr. 2021 Jul 1;114(1):59-69. doi: 10.1093/ajcn/nqab026.
PubMed 33826695van Westing AC, Eckl MR, Kupers LK, Pertiwi K, Hoogeveen EK, Geleijnse JM. Plasma fatty acids and kidney function decline in post-myocardial infarction patients of the Alpha Omega Cohort. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1467-1476. doi: 10.1016/j.numecd.2021.01.012. Epub 2021 Jan 29.
PubMed 33744039Esmeijer K, Geleijnse JM, Giltay EJ, Stijnen T, Dekker FW, de Fijter JW, Kromhout D, Hoogeveen EK. Body-fat indicators and kidney function decline in older post-myocardial infarction patients: The Alpha Omega Cohort Study. Eur J Prev Cardiol. 2018 Jan;25(1):90-99. doi: 10.1177/2047487317739986. Epub 2017 Nov 2.
PubMed 29095051Rius-Ottenheim N, Kromhout D, Sijtsma FPC, Geleijnse JM, Giltay EJ. Dietary patterns and mental health after myocardial infarction. PLoS One. 2017 Oct 16;12(10):e0186368. doi: 10.1371/journal.pone.0186368. eCollection 2017.
PubMed 29036212van Dongen LH, Molenberg FJ, Soedamah-Muthu SS, Kromhout D, Geleijnse JM. Coffee consumption after myocardial infarction and risk of cardiovascular mortality: a prospective analysis in the Alpha Omega Cohort. Am J Clin Nutr. 2017 Oct;106(4):1113-1120. doi: 10.3945/ajcn.117.153338. Epub 2017 Aug 23.
PubMed 28835365