Clinical trial NCT03015064: Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study
Official title: Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Infarction
Lead sponsor: Instituto de Cardiologia de Santa Catarina
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 1426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: MACE in 1 year
timeFrame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
measure: MACE in 30 days
timeFrame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
measure: Death in 1 year
timeFrame: Death incidence in 1 year
measure: Death in 30 days
timeFrame: Death incidence in 30 days
measure: Restenosis in 1 year
timeFrame: Restenosis incidence in 1 year
measure: Restenosis in 30 days
timeFrame: Restenosis incidence in 30 days
measure: Intrastent thrombosis in 1 year
timeFrame: Intrastent thrombosis incidence in 30 days
measure: Intrastent thrombosis in 30 days
timeFrame: Intrastent thrombosis incidence in 30 days
measure: Cardiovascular death in 1 year
timeFrame: Cardiovascular death incidence in 1 year
measure: Cardiovascular death in 30 days
timeFrame: Cardiovascular death incidence in 30 days
measure: Nonfatal infarction in 1 year
timeFrame: Nonfatal infarction incidence in 1 year
measure: Nonfatal infarction in 30 days
timeFrame: Nonfatal infarction incidence in 30 days
measure: Unstable angina in 1 year
timeFrame: Unstable angina incidence in 1 year
measure: Unstable angina in 30 days
timeFrame: Unstable angina incidence in 30 days
measure: Stroke in 1 year
timeFrame: Stroke incidence in 1 year
measure: Stroke in 30 days
timeFrame: Stroke incidence in 30 days
Secondary outcomes:
measure: Epidemiological profile
timeFrame: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
measure: Fish consumption
timeFrame: Fish consumption at admission
measure: Red meat consumption
timeFrame: Red meat consumption at admission
measure: Chocolate consumption
timeFrame: Chocolate consumption at admission
measure: Caffeine consumption
timeFrame: Caffeine consumption at admission
measure: Alcoholic beverages consumption
timeFrame: Alcoholic beverages consumption at admission
measure: Illegal drugs consumption
timeFrame: Illegal drugs consumption at admission
measure: Cognitive level
timeFrame: Cognitive level at admission
measure: Religiosity
timeFrame: Religiosity at admission
measure: Pre-infarct physical activity
timeFrame: Pre-infarct physical activity at admission
measure: Depression
timeFrame: Depression at admission
measure: Syntax score
timeFrame: Syntax score at admission
measure: TIMI frame count
timeFrame: TIMI frame count in patients with primary angioplasty at admission
measure: Ventricular function post-infarction
timeFrame: Ventricular function post-infarction (evaluated within 72 hours of admission)
measure: Hospitalization in 1 year
timeFrame: Hospitalization incidence in 1 year
measure: Hospitalization in 30 days
timeFrame: Hospitalization incidence in 30 days
measure: Bleeding in 1 year
timeFrame: Bleeding incidence in 1 year
measure: Bleeding in 30 days
timeFrame: Bleeding incidence in 30 days
measure: Hematocrit and hemoglobin
timeFrame: Hematocrit and hemoglobin at the admission
measure: Hematocrit and hemoglobin in 72 hours
timeFrame: Hematocrit and hemoglobin in 72 hours
measure: Red Cell Distribution Width (RDW)
timeFrame: Red Cell Distribution Width (RDW) at admission
measure: Red Cell Distribution Width (RDW)
timeFrame: Red Cell Distribution Width (RDW) in 72 hours
measure: Leukocytes
timeFrame: Leukocytes at admission
measure: Leukocytes
timeFrame: Leukocytes in 72 hours
measure: Creatinine
timeFrame: Creatinine at admission
measure: Creatinine
timeFrame: Creatinine in 72 hours
measure: Troponin levels
timeFrame: Troponin levels at admission
measure: Troponin levels
timeFrame: Troponin levels in 72 hours
measure: Cholesterol levels
timeFrame: Cholesterol levels at admission
measure: Cholesterol levels
timeFrame: Cholesterol levels in 72 hours
measure: C-reactive protein
timeFrame: C-reactive protein at admission
measure: C-reactive protein
timeFrame: C-reactive protein in 72 hours
measure: CHA2DS2-VASc Score
timeFrame: CHA2DS2-VASc Score at admission
Other outcomes:
Locations:
city: São José
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: Santa Catarina
Study officials:
References: