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NCT Number: NCT03015064

Post-Myocardial Infarction Patients in Santa Catarina, Brazil - 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myocardial Infarction

Other

Observational study of myocardial Infarction patients

Primary outcomes

  1. MACE in 1 year

    Time frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year

  2. MACE in 30 days

    Time frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days

  3. Death in 1 year

    Time frame: Death incidence in 1 year

  4. Death in 30 days

    Time frame: Death incidence in 30 days

  5. Restenosis in 1 year

    Time frame: Restenosis incidence in 1 year

  6. Restenosis in 30 days

    Time frame: Restenosis incidence in 30 days

  7. Intrastent thrombosis in 1 year

    Time frame: Intrastent thrombosis incidence in 30 days

  8. Intrastent thrombosis in 30 days

    Time frame: Intrastent thrombosis incidence in 30 days

  9. Cardiovascular death in 1 year

    Time frame: Cardiovascular death incidence in 1 year

  10. Cardiovascular death in 30 days

    Time frame: Cardiovascular death incidence in 30 days

  11. Nonfatal infarction in 1 year

    Time frame: Nonfatal infarction incidence in 1 year

  12. Nonfatal infarction in 30 days

    Time frame: Nonfatal infarction incidence in 30 days

  13. Unstable angina in 1 year

    Time frame: Unstable angina incidence in 1 year

  14. Unstable angina in 30 days

    Time frame: Unstable angina incidence in 30 days

  15. Stroke in 1 year

    Time frame: Stroke incidence in 1 year

  16. Stroke in 30 days

    Time frame: Stroke incidence in 30 days

Secondary outcomes

  1. Epidemiological profile

    Time frame: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Hospitalization in 1 year

    Time frame: Hospitalization incidence in 1 year

  16. Hospitalization in 30 days

    Time frame: Hospitalization incidence in 30 days

  17. Bleeding in 1 year

    Time frame: Bleeding incidence in 1 year

  18. Bleeding in 30 days

    Time frame: Bleeding incidence in 30 days

  19. Hematocrit and hemoglobin

    Time frame: Hematocrit and hemoglobin at the admission

  20. Hematocrit and hemoglobin in 72 hours

    Time frame: Hematocrit and hemoglobin in 72 hours

  21. Red Cell Distribution Width (RDW)

    Time frame: Red Cell Distribution Width (RDW) at admission

  22. Red Cell Distribution Width (RDW)

    Time frame: Red Cell Distribution Width (RDW) in 72 hours

  23. Leukocytes

    Time frame: Leukocytes at admission

  24. Leukocytes

    Time frame: Leukocytes in 72 hours

  25. Creatinine

    Time frame: Creatinine at admission

  26. Creatinine

    Time frame: Creatinine in 72 hours

  27. Troponin levels

    Time frame: Troponin levels at admission

  28. Troponin levels

    Time frame: Troponin levels in 72 hours

  29. Cholesterol levels

    Time frame: Cholesterol levels at admission

  30. Cholesterol levels

    Time frame: Cholesterol levels in 72 hours

  31. C-reactive protein

    Time frame: C-reactive protein at admission

  32. C-reactive protein

    Time frame: C-reactive protein in 72 hours

  33. 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

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia de Santa Catarina

Other

Registry information

Official study title

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

Acronym: Catarina

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2017
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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