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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
What is being tested?
Dietary intake, Lifestyle factors and Blood biomarkers
How many people
4,837 participants
Where
1 siteNetherlands
Study dates
Apr 2002to Jan 2040
Phase
Observational
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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

Other trials in Netherlands

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.

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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Kidney function

    Change in serum cystatin C-based estimated glomerular filtration rate

    Measured: From entry into the study (baseline: 2002-2006) until November 2009

  6. 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.

  1. First posted20 Jun 2017
  2. Study startApr 2002
  3. Primary completionJan 2040 (estimated)
  4. Study completionJan 2040 (estimated)

Resources

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)
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 20362710

  • 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.

    PubMed 20929341

  • 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 Nutr. 2015 Dec;102(6):1527-33. doi: 10.3945/ajcn.115.112276. Epub 2015 Oct 21.

    PubMed 26490494

  • 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.10441013. Epub 2014 Aug 7.

    PubMed 25104273

  • 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 baseline data. BMJ Open. 2012 Oct 31;2(6):e001360. doi: 10.1136/bmjopen-2012-001360. Print 2012.

    PubMed 23117562

  • 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 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 22314614

  • Evers 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 36035961

  • Cruijsen 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 35155529

  • Pertiwi 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 34845924

  • Cruijsen 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 34734223

  • Cruijsen 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 33826695

  • van 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 33744039

  • Esmeijer 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 29095051

  • Rius-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 29036212

  • van 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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Mortality, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular mortality (time frame: From entry into the study (baseline: 2002-2006) through study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192410, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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