- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015064
Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study (Catarina)
July 28, 2024 updated by: Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study
Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the diagnosis of the first acute myocardial infarction from July 2016 until December 2020.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1426
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
-
-
Santa Catarina
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São José, Santa Catarina, Brazil
- Instituto de Cardiologia de Santa Catarina
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients attended at the Santa Catarina Institute of Cardiology and other hospitals in the State of Santa Catarina with the diagnosis of the first acute myocardial infarction
Description
Inclusion Criteria:
- Age over 18 years;
- Presence of precordial pain suggestive of acute myocardial infarction associated with electrocardiogram with new ST segment elevation in two contiguous leads with limits: ≥0.1 mv in all leads other than leads V2-V3 where the following limits apply : ≥0.2 mv in Men ≥40 years; ≥0.25 mV in men <40 years, or ≥ 0.15 mV in women or presence of precordial pain suggestive of acute myocardial infarction associated with elevation of troponin I or CK-MB above the 99th percentile of the upper reference limit
Exclusion Criteria:
- Previous acute myocardial infarction;
- Disagreement with the Terms of Informed Consent.
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 |
Intervention / Treatment |
|---|---|
|
Myocardial Infarction
Patients with first myocardial Infarction
|
Observational study of myocardial Infarction patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MACE in 1 year
Time Frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
|
Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
|
|
MACE in 30 days
Time Frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
|
Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
|
|
Death in 1 year
Time Frame: Death incidence in 1 year
|
Death incidence in 1 year
|
|
Death in 30 days
Time Frame: Death incidence in 30 days
|
Death incidence in 30 days
|
|
Restenosis in 1 year
Time Frame: Restenosis incidence in 1 year
|
Restenosis incidence in 1 year
|
|
Restenosis in 30 days
Time Frame: Restenosis incidence in 30 days
|
Restenosis incidence in 30 days
|
|
Intrastent thrombosis in 1 year
Time Frame: Intrastent thrombosis incidence in 30 days
|
Intrastent thrombosis incidence in 30 days
|
|
Intrastent thrombosis in 30 days
Time Frame: Intrastent thrombosis incidence in 30 days
|
Intrastent thrombosis incidence in 30 days
|
|
Cardiovascular death in 1 year
Time Frame: Cardiovascular death incidence in 1 year
|
Cardiovascular death incidence in 1 year
|
|
Cardiovascular death in 30 days
Time Frame: Cardiovascular death incidence in 30 days
|
Cardiovascular death incidence in 30 days
|
|
Nonfatal infarction in 1 year
Time Frame: Nonfatal infarction incidence in 1 year
|
Nonfatal infarction incidence in 1 year
|
|
Nonfatal infarction in 30 days
Time Frame: Nonfatal infarction incidence in 30 days
|
Nonfatal infarction incidence in 30 days
|
|
Unstable angina in 1 year
Time Frame: Unstable angina incidence in 1 year
|
Unstable angina incidence in 1 year
|
|
Unstable angina in 30 days
Time Frame: Unstable angina incidence in 30 days
|
Unstable angina incidence in 30 days
|
|
Stroke in 1 year
Time Frame: Stroke incidence in 1 year
|
Stroke incidence in 1 year
|
|
Stroke in 30 days
Time Frame: Stroke incidence in 30 days
|
Stroke incidence in 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epidemiological profile
Time Frame: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
|
Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
|
|
|
Fish consumption
Time Frame: Fish consumption at admission
|
Fish consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Fish consumption at admission
|
|
Red meat consumption
Time Frame: Red meat consumption at admission
|
Read meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Red meat consumption at admission
|
|
Chocolate consumption
Time Frame: Chocolate consumption at admission
|
Red meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Chocolate consumption at admission
|
|
Caffeine consumption
Time Frame: Caffeine consumption at admission
|
Caffeine consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Caffeine consumption at admission
|
|
Alcoholic beverages consumption
Time Frame: Alcoholic beverages consumption at admission
|
Alcoholic beverages consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Alcoholic beverages consumption at admission
|
|
Illegal drugs consumption
Time Frame: Illegal drugs consumption at admission
|
Illegal drugs consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Illegal drugs consumption at admission
|
|
Cognitive level
Time Frame: Cognitive level at admission
|
Cognitive level (evaluated with Mini-Mental State Examination) at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction syndromes and infarction
|
Cognitive level at admission
|
|
Religiosity
Time Frame: Religiosity at admission
|
Religiosity (evaluated with Duke University Religion Index) at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Religiosity at admission
|
|
Pre-infarct physical activity
Time Frame: Pre-infarct physical activity at admission
|
Pre-infarct (evaluated with Baecke Questionnaire) physical activity at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Pre-infarct physical activity at admission
|
|
Depression
Time Frame: Depression at admission
|
Depression (evaluated with PHQ-9: Patient Health Questionnaire-9) at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Depression at admission
|
|
Syntax score
Time Frame: Syntax score at admission
|
Syntax score at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Syntax score at admission
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|
TIMI frame count
Time Frame: TIMI frame count in patients with primary angioplasty at admission
|
TIMI frame count in patients with primary angioplasty at admission its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
TIMI frame count in patients with primary angioplasty at admission
|
|
Ventricular function post-infarction
Time Frame: Ventricular function post-infarction (evaluated within 72 hours of admission)
|
Ventricular function (ventricular ejection fraction), its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
Ventricular function post-infarction (evaluated within 72 hours of admission)
|
|
Hospitalization in 1 year
Time Frame: Hospitalization incidence in 1 year
|
Hospitalization incidence in 1 year
|
|
|
Hospitalization in 30 days
Time Frame: Hospitalization incidence in 30 days
|
Hospitalization incidence in 30 days
|
|
|
Bleeding in 1 year
Time Frame: Bleeding incidence in 1 year
|
Bleeding incidence in 1 year
|
|
|
Bleeding in 30 days
Time Frame: Bleeding incidence in 30 days
|
Bleeding incidence in 30 days
|
|
|
Hematocrit and hemoglobin
Time Frame: Hematocrit and hemoglobin at the admission
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Hematocrit and hemoglobin at the admission
|
|
|
Hematocrit and hemoglobin in 72 hours
Time Frame: Hematocrit and hemoglobin in 72 hours
|
Hematocrit and hemoglobin in 72 hours
|
|
|
Red Cell Distribution Width (RDW)
Time Frame: Red Cell Distribution Width (RDW) at admission
|
Red Cell Distribution Width (RDW) at admission
|
|
|
Red Cell Distribution Width (RDW)
Time Frame: Red Cell Distribution Width (RDW) in 72 hours
|
Red Cell Distribution Width (RDW) in 72 hours
|
|
|
Leukocytes
Time Frame: Leukocytes at admission
|
Leukocytes at admission
|
|
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Leukocytes
Time Frame: Leukocytes in 72 hours
|
Leukocytes in 72 hours
|
|
|
Creatinine
Time Frame: Creatinine at admission
|
Creatinine at admission
|
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Creatinine
Time Frame: Creatinine in 72 hours
|
Creatinine in 72 hours
|
|
|
Troponin levels
Time Frame: Troponin levels at admission
|
Troponin levels at admission
|
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Troponin levels
Time Frame: Troponin levels in 72 hours
|
Troponin levels in 72 hours
|
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|
Cholesterol levels
Time Frame: Cholesterol levels at admission
|
Cholesterol levels at admission
|
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Cholesterol levels
Time Frame: Cholesterol levels in 72 hours
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Cholesterol levels in 72 hours
|
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C-reactive protein
Time Frame: C-reactive protein at admission
|
C-reactive protein at admission
|
|
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C-reactive protein
Time Frame: C-reactive protein in 72 hours
|
C-reactive protein in 72 hours
|
|
|
CHA2DS2-VASc Score
Time Frame: CHA2DS2-VASc Score at admission
|
CHA2DS2-VASc Score, its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
|
CHA2DS2-VASc Score at admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
July 1, 2016
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 30, 2016
First Submitted That Met QC Criteria
January 6, 2017
First Posted (Estimated)
January 9, 2017
Study Record Updates
Last Update Posted (Actual)
July 30, 2024
Last Update Submitted That Met QC Criteria
July 28, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 55450816.0.1001.0113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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