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

NCT ID: NCT03192410

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4837 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-04-30

Study Completion Date

2040-01-31

Brief Summary

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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

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Details are reported in publications.

Conditions

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Cardiovascular Diseases Mortality Type 2 Diabetes Mellitus Cognitive Decline Mental Well-being Kidney Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dietary intake

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

Intervention Type BEHAVIORAL

Lifestyle factors

Physical activity; smoking; alcohol use; educational level.

Intervention Type BEHAVIORAL

Blood biomarkers

Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.

Intervention Type 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)

Intervention Type BIOLOGICAL

DNA

SNPs (GWAS)

Intervention Type GENETIC

Mental well-being

Cognitive function; dispositional optimism; depression.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Geleijnse

Professor of Nutrition and Cardiovascular Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johanna M Geleijnse, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University, Division of Human Nutrition

Locations

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Wageningen University, Division of Human Nutrition

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 20362710 (View on PubMed)

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.

Reference Type RESULT
PMID: 20929341 (View on PubMed)

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.

Reference Type RESULT
PMID: 26490494 (View on PubMed)

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.

Reference Type RESULT
PMID: 25104273 (View on PubMed)

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.

Reference Type RESULT
PMID: 23117562 (View on PubMed)

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.

Reference Type RESULT
PMID: 22314614 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36035961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35155529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34845924 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34734223 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33826695 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33744039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29095051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29036212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28835365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28793994 (View on PubMed)

Related Links

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http://www.alphaomegatrial.com

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

Other Identifiers

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Alpha Omega Cohort

Identifier Type: -

Identifier Source: org_study_id

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