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A Case-control Study of Costa Rican Adults With Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03308838
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Universidad de Costa Rica
Harvard School of Public Health
Information provided by (Responsible Party):
Ana Baylin, University of Michigan

Brief 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.

Condition or disease
Myocardial Infarction, Acute

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Study Type : Observational
Actual Enrollment : 4547 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Actual Study Start Date : August 1, 1994
Actual Primary Completion Date : August 1, 2004
Actual Study Completion Date : August 1, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
Cases
Cases consisted of Costa Rican adults who were diagnosed as survivors of a first acute myocardial infarction.
Controls
Controls consisted of healthy individuals randomly identified from the underlying source population in Costa Rica and matched to each case by age, sex, and area of residence.



Primary Outcome Measures :
  1. Nonfatal Acute Myocardial Infarction [ Time Frame: 1994-2004 ]
    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.


Biospecimen Retention:   Samples With DNA
We collected adipose tissue biopsies to quantify adipose tissue fatty acids.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Cases were survivors of a first acute MI as diagnosed by a cardiologist at any of the six recruiting hospitals in the Central Valley of Costa Rica. Controls were population-based controls from Costa Rica.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308838


Locations
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Costa Rica
University of Costa Rica
San Pedro, San José, Costa Rica
Sponsors and Collaborators
University of Michigan
Universidad de Costa Rica
Harvard School of Public Health
Investigators
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Principal Investigator: Ana Baylin, MD, DrPH University of Michigan

Publications of Results:
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Responsible Party: Ana Baylin, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03308838     History of Changes
Other Study ID Numbers: HUM00037337
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data are completely de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases