Myocardial Infarction, AcuteNCT03308838
A Case-control Study of Costa Rican Adults With Myocardial Infarction
An observational study of Myocardial Infarction, Acute, run by University of Michigan at 1 site in Costa Rica.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 4,547 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 Aug 1994to 1 Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Cases were eligible if they met the World Health Organization criteria for MI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myocardial Infarction, Acute
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1994-2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Aug 1994
- Primary completion1 Aug 2004
- Study completion1 Aug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Costa Rica, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Ana Baylin, University of Michigan
- Investigators
- Ana Baylin, MD, DrPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308838
- Sponsor's protocol ID
- HUM00037337
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are completely de-identified.
Publications
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.
PubMed 11880764Baylin 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.
PubMed 12668490Baylin 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.
PubMed 12672941Kabagambe 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.
PubMed 17339565Aslibekyan 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.
PubMed 21562240Wang 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.
PubMed 28875869
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of Costa Rican Adults With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03308838
- Acronym / sponsor ID
- HUM00037337
- Conditions
- Myocardial Infarction, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,547 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Universidad de Costa Rica, Harvard School of Public Health (HSPH)
- Study start
- 1 Aug 1994 (actual)
- Primary completion
- 1 Aug 2004 (actual)
- Study completion
- 1 Aug 2004 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Cases were eligible if they met the World Health Organization criteria for MI
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Results publication: PubMed 11880764El-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.
- Results publication: PubMed 12668490Baylin 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.
- Results publication: PubMed 12672941Baylin 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.
- Results publication: PubMed 17339565Kabagambe 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.
- Results publication: PubMed 21562240Aslibekyan 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.
- Results publication: PubMed 28875869Wang 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.
- Individual participant dataSharing planned: No. The data are completely de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Baylin, MD, DrPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, Acute, run by University of Michigan at 1 site in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nonfatal Acute Myocardial Infarction (time frame: 1994-2004). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308838, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.