Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study

Myocardial Infarction Clinical Trial

— Catarina  

Official title:

Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03015064
• Other study ID #: CAAE: 55450816.0.1001.0113
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 6, 2017
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2017
• Source: Instituto de Cardiologia de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1426
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Myocardial Infarction
Observational study of myocardial Infarction patients

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia de Santa Catarina	São José	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE in 1 year		Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year	No
Primary	MACE in 30 days		Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days	No
Primary	Death in 1 year		Death incidence in 1 year	No
Primary	Death in 30 days		Death incidence in 30 days	No
Primary	Restenosis in 1 year		Restenosis incidence in 1 year	No
Primary	Restenosis in 30 days		Restenosis incidence in 30 days	No
Primary	Intrastent thrombosis in 1 year		Intrastent thrombosis incidence in 30 days	No
Primary	Intrastent thrombosis in 30 days		Intrastent thrombosis incidence in 30 days	No
Primary	Cardiovascular death in 1 year		Cardiovascular death incidence in 1 year	No
Primary	Cardiovascular death in 30 days		Cardiovascular death incidence in 30 days	No
Primary	Nonfatal infarction in 1 year		Nonfatal infarction incidence in 1 year	No
Primary	Nonfatal infarction in 30 days		Nonfatal infarction incidence in 30 days	No
Primary	Unstable angina in 1 year		Unstable angina incidence in 1 year	No
Primary	Unstable angina in 30 days		Unstable angina incidence in 30 days	No
Primary	Stroke in 1 year		Stroke incidence in 1 year	No
Primary	Stroke in 30 days		Stroke incidence in 30 days	No
Secondary	Epidemiological profile		Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission	No
Secondary	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	Fish consumption at admission	No
Secondary	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	Red meat consumption at admission	No
Secondary	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	Chocolate consumption at admission	No
Secondary	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	Caffeine consumption at admission	No
Secondary	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	Alcoholic beverages consumption at admission	No
Secondary	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	Illegal drugs consumption at admission	No
Secondary	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	Cognitive level at admission	No
Secondary	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	Religiosity at admission	No
Secondary	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	Pre-infarct physical activity at admission	No
Secondary	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	Depression at admission	No
Secondary	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	Syntax score at admission	No
Secondary	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	TIMI frame count in patients with primary angioplasty at admission	No
Secondary	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	Ventricular function post-infarction (evaluated within 72 hours of admission)	No
Secondary	Hospitalization in 1 year		Hospitalization incidence in 1 year	No
Secondary	Hospitalization in 30 days		Hospitalization incidence in 30 days	No
Secondary	Bleeding in 1 year		Bleeding incidence in 1 year	No
Secondary	Bleeding in 30 days		Bleeding incidence in 30 days	No
Secondary	Hematocrit and hemoglobin		Hematocrit and hemoglobin at the admission	No
Secondary	Hematocrit and hemoglobin in 72 hours		Hematocrit and hemoglobin in 72 hours	No
Secondary	Red Cell Distribution Width (RDW)		Red Cell Distribution Width (RDW) at admission	No
Secondary	Red Cell Distribution Width (RDW)		Red Cell Distribution Width (RDW) in 72 hours	No
Secondary	Leukocytes		Leukocytes at admission	No
Secondary	Leukocytes		Leukocytes in 72 hours	No
Secondary	Creatinine		Creatinine at admission	No
Secondary	Creatinine		Creatinine in 72 hours	No
Secondary	Troponin levels		Troponin levels at admission	No
Secondary	Troponin levels		Troponin levels in 72 hours	No
Secondary	Cholesterol levels		Cholesterol levels at admission	No
Secondary	Cholesterol levels		Cholesterol levels in 72 hours	No
Secondary	C-reactive protein		C-reactive protein at admission	No
Secondary	C-reactive protein		C-reactive protein in 72 hours	No
Secondary	CHA2DS2-VASc Score	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	No