Clinical trial NCT03192410: Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
Official title: Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Mortality
Type 2 Diabetes Mellitus
Cognitive Decline
Mental Well-being
Kidney Function
Keywords: myocardial infarction
cardiovascular diseases
mortality
post-myocardial infarction patients
risk prediction
kidney function
mental well-being
cardiovascular drug treatment
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 4837
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: Details are reported in publications.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: From entry into the study (baseline: 2002-2006) through study completion
measure: All-cause mortality
timeFrame: From entry into the study (baseline: 2002-2006) through study completion
measure: Major cardiovascular events
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
Secondary outcomes:
measure: Coronary heart disease
timeFrame: From entry into the study (baseline: 2002-2006) through study completion
measure: Stroke
timeFrame: From entry into the study (baseline: 2002-2006) through study completion
measure: Non-cardiovascular mortality
timeFrame: From entry into the study (baseline: 2002-2006) through study completion
measure: Type 2 diabetes
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Kidney function
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Cognitive function
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
Other outcomes:
measure: Depression
timeFrame: After 40 months of follow-up
measure: Dispositional optimism
timeFrame: After 40 months of follow-up
measure: Body weight
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Blood pressure
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Blood lipids
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Glucose metabolism
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: DNA genotype
timeFrame: At baseline (2002-2006)
measure: Biochemical markers of Inflammation
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Biochemical markers of endothelial function
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Biomarkers of cardiac function
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Biomarkers of kidney function
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Prostate-specific antigen (PSA)
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Testosterone
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
measure: Circulating fatty acids
timeFrame: From entry into the study (baseline: 2002-2006) until November 2009
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: Wageningen University, Division of Human Nutrition
name: Johanna M Geleijnse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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 Nutr. 2015 Dec;102(6):1527-33. doi: 10.3945/ajcn.115.112276. Epub 2015 Oct 21.
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.10441013. Epub 2014 Aug 7.
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 baseline data. BMJ Open. 2012 Oct 31;2(6):e001360. doi: 10.1136/bmjopen-2012-001360. Print 2012.
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 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.