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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03308838
Other study ID # HUM00037337
Secondary ID
Status Completed
Phase N/A
First received October 9, 2017
Last updated October 9, 2017
Start date August 1, 1994
Est. completion date August 1, 2004

Study information

Verified date October 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational case-control trial sought to identify and characterize different exposures associated with nonfatal acute myocardial infarction in Costa Rican adults. Exposures assessed included dietary variables and adipose tissue fatty acids.


Recruitment information / eligibility

Status Completed
Enrollment 4547
Est. completion date August 1, 2004
Est. primary completion date August 1, 2004
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Cases were eligible if they met the World Health Organization criteria for MI

Exclusion Criteria (Cases):

- Died during hospitalization

- Were 75 years or older on the day of their first MI

- Were physically or mentally unable to answer the questionnaire

- Had a previous hospital admission related to cardiovascular disease

Exclusion Criteria (Controls):

- Ever had an MI

- Were physically or mentally unable to answer the questionnaire

Study Design


Locations

Country Name City State
Costa Rica University of Costa Rica San Pedro San José

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan Harvard School of Public Health, University of Costa Rica

Country where clinical trial is conducted

Costa Rica, 

References & Publications (6)

Aslibekyan S, Campos H, Loucks EB, Linkletter CD, Ordovas JM, Baylin A. Development of a cardiovascular risk score for use in low- and middle-income countries. J Nutr. 2011 Jul;141(7):1375-80. doi: 10.3945/jn.110.133140. Epub 2011 May 11. — View Citation

Baylin A, Kabagambe EK, Ascherio A, Spiegelman D, Campos H. Adipose tissue alpha-linolenic acid and nonfatal acute myocardial infarction in Costa Rica. Circulation. 2003 Apr 1;107(12):1586-91. Epub 2003 Mar 10. — View Citation

Baylin A, Kabagambe EK, Ascherio A, Spiegelman D, Campos H. High 18:2 trans-fatty acids in adipose tissue are associated with increased risk of nonfatal acute myocardial infarction in costa rican adults. J Nutr. 2003 Apr;133(4):1186-91. — View Citation

El-Sohemy A, Baylin A, Spiegelman D, Ascherio A, Campos H. Dietary and adipose tissue gamma-tocopherol and risk of myocardial infarction. Epidemiology. 2002 Mar;13(2):216-23. — View Citation

Kabagambe EK, Baylin A, Campos H. Nonfatal acute myocardial infarction in Costa Rica: modifiable risk factors, population-attributable risks, and adherence to dietary guidelines. Circulation. 2007 Mar 6;115(9):1075-81. — View Citation

Wang D, Campos H, Baylin A. Red meat intake is positively associated with non-fatal acute myocardial infarction in the Costa Rica Heart Study. Br J Nutr. 2017 Aug;118(4):303-311. doi: 10.1017/S000711451700201X. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nonfatal Acute Myocardial Infarction Identified by independent examinations of two cardiologists at any of the six recruiting hospitals in the catchment area of the Central Valley of Costa Rica. Outcome was determined as being met if they met the World Health Organization criteria for myocardial infarction. 1994-2004
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