NCT03192410

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,837

participants targeted

Target at P75+ for all trials

Timeline
167mo left

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2002Jan 2040

Study Start

First participant enrolled

April 1, 2002

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
22.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

37.8 years

First QC Date

June 10, 2017

Last Update Submit

June 15, 2017

Conditions

Cardiovascular DiseasesMortalityType 2 Diabetes MellitusCognitive DeclineMental Well-beingKidney Function

Keywords

myocardial infarctioncardiovascular diseasesmortalitypost-myocardial infarction patientsrisk predictionkidney functionmental well-beingcardiovascular drug treatment

Outcome Measures

Primary Outcomes (3)

  • 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

  • All-cause mortality

    Vital status obtained from municipal population registers in the Netherlands

    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

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

Secondary Outcomes (6)

  • Coronary heart disease

    From entry into the study (baseline: 2002-2006) through study completion

  • Stroke

    From entry into the study (baseline: 2002-2006) through study completion

  • Non-cardiovascular mortality

    From entry into the study (baseline: 2002-2006) through study completion

  • Type 2 diabetes

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

  • Kidney function

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

  • +1 more secondary outcomes

Other Outcomes (14)

  • Depression

    After 40 months of follow-up

  • Dispositional optimism

    After 40 months of follow-up

  • Body weight

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

  • +11 more other outcomes

Interventions

Dietary intakeBEHAVIORAL

Intake of nutrients, foods, food groups, beverages; dietary patterns.

Lifestyle factorsBEHAVIORAL

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.

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, 6700 AA, Netherlands

Location

Related Publications (16)

  • 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.

    PMID: 20362710BACKGROUND

  • 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.

    PMID: 20929341RESULT

  • 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.

    PMID: 26490494RESULT

  • 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.

    PMID: 25104273RESULT

  • 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.

    PMID: 23117562RESULT

  • 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.

    PMID: 22314614RESULT

  • 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.

    PMID: 36035961DERIVED

  • 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.

    PMID: 35155529DERIVED

  • 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.

    PMID: 34845924DERIVED

  • 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.

    PMID: 34734223DERIVED

  • 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.

    PMID: 33826695DERIVED

  • 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.

    PMID: 33744039DERIVED

  • 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.

    PMID: 29095051DERIVED

  • 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.

    PMID: 29036212DERIVED

  • 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.

    PMID: 28835365DERIVED

  • Molenberg FJM, de Goede J, Wanders AJ, Zock PL, Kromhout D, Geleijnse JM. Dietary fatty acid intake after myocardial infarction: a theoretical substitution analysis of the Alpha Omega Cohort. Am J Clin Nutr. 2017 Sep 1;106(3):895-901. doi: 10.3945/ajcn.117.157826.

    PMID: 28793994DERIVED

Related Links

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.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2Cognitive DysfunctionPsychological Well-BeingMyocardial Infarction

Interventions

EatingHealthDNAMental Health

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPersonal SatisfactionBehaviorMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaPopulation CharacteristicsNucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Johanna M Geleijnse, PhD

    Wageningen University, Division of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Cardiovascular Disease

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 20, 2017

Study Start

April 1, 2002

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

January 1, 2040

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

NL(1)