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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Brazil
    • Santa Catarina
      • São José, Santa Catarina, Brazil
        • Instituto de Cardiologia de Santa Catarina

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Myocardial Infarction
Patients with first myocardial Infarction
Other: Myocardial Infarction
Observational study of myocardial Infarction patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
Leukocytes
Time Frame: Leukocytes in 72 hours
Leukocytes in 72 hours
Creatinine
Time Frame: Creatinine at admission
Creatinine at admission
Creatinine
Time Frame: Creatinine in 72 hours
Creatinine in 72 hours
Troponin levels
Time Frame: Troponin levels at admission
Troponin levels at admission
Troponin levels
Time Frame: Troponin levels in 72 hours
Troponin levels in 72 hours
Cholesterol levels
Time Frame: Cholesterol levels at admission
Cholesterol levels at admission
Cholesterol levels
Time Frame: Cholesterol levels in 72 hours
Cholesterol levels in 72 hours
C-reactive protein
Time Frame: C-reactive protein at admission
C-reactive protein at admission
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Cardiologia de Santa Catarina

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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