Myocardial InfarctionCatarinaNCT03015064
Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study
An observational study of Myocardial Infarction, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Myocardial Infarction
- How many people
- 1,426 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Previous acute myocardial infarction;
- Disagreement with the Terms of Informed Consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial InfarctionOther
Observational study of myocardial Infarction patients
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Infarction | Patients with first myocardial Infarction Receives: Other: Myocardial Infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE in 1 year
Measured: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
MACE in 30 days
Measured: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
Death in 1 year
Measured: Death incidence in 1 year
Death in 30 days
Measured: Death incidence in 30 days
Restenosis in 1 year
Measured: Restenosis incidence in 1 year
Restenosis in 30 days
Measured: Restenosis incidence in 30 days
Intrastent thrombosis in 1 year
Measured: Intrastent thrombosis incidence in 30 days
Intrastent thrombosis in 30 days
Measured: Intrastent thrombosis incidence in 30 days
Cardiovascular death in 1 year
Measured: Cardiovascular death incidence in 1 year
Cardiovascular death in 30 days
Measured: Cardiovascular death incidence in 30 days
Nonfatal infarction in 1 year
Measured: Nonfatal infarction incidence in 1 year
Nonfatal infarction in 30 days
Measured: Nonfatal infarction incidence in 30 days
Unstable angina in 1 year
Measured: Unstable angina incidence in 1 year
Unstable angina in 30 days
Measured: Unstable angina incidence in 30 days
Stroke in 1 year
Measured: Stroke incidence in 1 year
Stroke in 30 days
Measured: Stroke incidence in 30 days
Secondary outcomes (33)
Epidemiological profile
Measured: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
Fish consumption
Fish consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Fish consumption at admission
Red meat consumption
Read meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Red meat consumption at admission
Chocolate consumption
Red meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Chocolate consumption at admission
Caffeine consumption
Caffeine consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Caffeine consumption at admission
Alcoholic beverages consumption
Alcoholic beverages consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Alcoholic beverages consumption at admission
Illegal drugs consumption
Illegal drugs consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Illegal drugs consumption at admission
Cognitive level
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
Measured: Cognitive level at admission
Religiosity
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
Measured: Religiosity at admission
Pre-infarct physical activity
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
Measured: Pre-infarct physical activity at admission
Depression
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
Measured: Depression at admission
Syntax score
Syntax score at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Syntax score at admission
TIMI frame count
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
Measured: TIMI frame count in patients with primary angioplasty at admission
Ventricular function post-infarction
Ventricular function (ventricular ejection fraction), its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: Ventricular function post-infarction (evaluated within 72 hours of admission)
Hospitalization in 1 year
Measured: Hospitalization incidence in 1 year
Hospitalization in 30 days
Measured: Hospitalization incidence in 30 days
Bleeding in 1 year
Measured: Bleeding incidence in 1 year
Bleeding in 30 days
Measured: Bleeding incidence in 30 days
Hematocrit and hemoglobin
Measured: Hematocrit and hemoglobin at the admission
Hematocrit and hemoglobin in 72 hours
Measured: Hematocrit and hemoglobin in 72 hours
Red Cell Distribution Width (RDW)
Measured: Red Cell Distribution Width (RDW) at admission
Red Cell Distribution Width (RDW)
Measured: Red Cell Distribution Width (RDW) in 72 hours
Leukocytes
Measured: Leukocytes at admission
Leukocytes
Measured: Leukocytes in 72 hours
Creatinine
Measured: Creatinine at admission
Creatinine
Measured: Creatinine in 72 hours
Troponin levels
Measured: Troponin levels at admission
Troponin levels
Measured: Troponin levels in 72 hours
Cholesterol levels
Measured: Cholesterol levels at admission
Cholesterol levels
Measured: Cholesterol levels in 72 hours
C-reactive protein
Measured: C-reactive protein at admission
C-reactive protein
Measured: C-reactive protein in 72 hours
CHA2DS2-VASc Score
CHA2DS2-VASc Score, its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
Measured: CHA2DS2-VASc Score at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015064
- Sponsor's protocol ID
- CAAE: 55450816.0.1001.0113
- Acronym
- Catarina
- Status last verified
- Jul 2024
- First submitted
- 30 Dec 2016
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study
- ClinicalTrials.gov ID
- NCT03015064
- Acronym / sponsor ID
- Catarina / CAAE: 55450816.0.1001.0113
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,426 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia de Santa CatarinaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial Infarction | – | Other: Myocardial InfarctionPatients with first myocardial Infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Previous acute myocardial infarction;
- Disagreement with the Terms of Informed Consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial InfarctionObservational study of myocardial Infarction patients | Other | Myocardial Infarction |
Primary outcome
MACE in 1 year
Time frame: 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
Death in 1 year
Time frame: Death incidence in 1 year
Death in 30 days
Time frame: Death incidence in 30 days
Restenosis in 1 year
Time frame: Restenosis incidence in 1 year
Restenosis in 30 days
Time frame: Restenosis incidence in 30 days
Intrastent thrombosis in 1 year
Time frame: Intrastent thrombosis incidence in 30 days
Intrastent thrombosis in 30 days
Time frame: Intrastent thrombosis incidence in 30 days
Cardiovascular death in 1 year
Time frame: Cardiovascular death incidence in 1 year
Cardiovascular death in 30 days
Time frame: Cardiovascular death incidence in 30 days
Nonfatal infarction in 1 year
Time frame: Nonfatal infarction incidence in 1 year
Nonfatal infarction in 30 days
Time frame: Nonfatal infarction incidence in 30 days
Unstable angina in 1 year
Time frame: Unstable angina incidence in 1 year
Unstable angina in 30 days
Time frame: Unstable angina incidence in 30 days
Stroke in 1 year
Time frame: Stroke incidence in 1 year
Stroke in 30 days
Time frame: Stroke incidence in 30 days
33 secondary outcomes
Epidemiological profile
Time frame: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
Fish consumption
Time frame: Fish consumption at admission
Red meat consumption
Time frame: Red meat consumption at admission
Chocolate consumption
Time frame: Chocolate consumption at admission
Caffeine consumption
Time frame: Caffeine consumption at admission
Alcoholic beverages consumption
Time frame: Alcoholic beverages consumption at admission
Illegal drugs consumption
Time frame: Illegal drugs consumption at admission
Cognitive level
Time frame: Cognitive level at admission
Religiosity
Time frame: Religiosity at admission
Pre-infarct physical activity
Time frame: Pre-infarct physical activity at admission
Depression
Time frame: Depression at admission
Syntax score
Time frame: Syntax score at admission
TIMI frame count
Time frame: 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)
Hospitalization in 1 year
Time frame: Hospitalization incidence in 1 year
Hospitalization in 30 days
Time frame: Hospitalization incidence in 30 days
Bleeding in 1 year
Time frame: Bleeding incidence in 1 year
Bleeding in 30 days
Time frame: Bleeding incidence in 30 days
Hematocrit and hemoglobin
Time frame: Hematocrit and hemoglobin at the admission
Hematocrit and hemoglobin in 72 hours
Time frame: 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)
Time frame: Red Cell Distribution Width (RDW) in 72 hours
Leukocytes
Time frame: Leukocytes at admission
Leukocytes
Time frame: Leukocytes in 72 hours
Creatinine
Time frame: Creatinine at admission
Creatinine
Time frame: Creatinine in 72 hours
Troponin levels
Time frame: Troponin levels at admission
Troponin levels
Time frame: Troponin levels in 72 hours
Cholesterol levels
Time frame: Cholesterol levels at admission
Cholesterol levels
Time frame: Cholesterol levels in 72 hours
C-reactive protein
Time frame: C-reactive protein at admission
C-reactive protein
Time frame: C-reactive protein in 72 hours
CHA2DS2-VASc Score
Time frame: CHA2DS2-VASc Score at admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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 Brazil. 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?
Results are not available in the source record.
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?
MACE in 1 year (time frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.