NCT03308838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

10 years

First QC Date

October 9, 2017

Last Update Submit

October 9, 2017

Conditions

Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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
  • Ever had an MI
  • Were physically or mentally unable to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Costa Rica

San Pedro, Provincia de San José, Costa Rica

Location

Related Publications (6)

  • 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. doi: 10.1097/00001648-200203000-00018.

    PMID: 11880764RESULT

  • 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. doi: 10.1161/01.CIR.0000058165.81208.C6. Epub 2003 Mar 10.

    PMID: 12668490RESULT

  • 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. doi: 10.1093/jn/133.4.1186.

    PMID: 12672941RESULT

  • 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. doi: 10.1161/CIRCULATIONAHA.106.643544.

    PMID: 17339565RESULT

  • 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.

    PMID: 21562240RESULT

  • 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.

    PMID: 28875869RESULT

Biospecimen

Retention: SAMPLES WITH DNA

We collected adipose tissue biopsies to quantify adipose tissue fatty acids.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ana Baylin, MD, DrPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

August 1, 1994

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

The data are completely de-identified.

Locations

CO(1)