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

October 9, 2017 updated by: Ana Baylin, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4547

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
    • San José
      • San Pedro, San José, Costa Rica
        • University of Costa Rica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1994-2004

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Harvard School of Public Health (HSPH)
Universidad de Costa Rica

Investigators

  • Principal Investigator: Ana Baylin, MD, DrPH, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 1994

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00037337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are completely de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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