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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015064
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina

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.

Condition or disease Intervention/treatment
Myocardial Infarction Other: Myocardial Infarction

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Study Type : Observational
Estimated Enrollment : 1426 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
Myocardial Infarction
Patients with first myocardial Infarction
Other: Myocardial Infarction
Observational study of myocardial Infarction patients




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015064


Locations
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Brazil
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, Brazil
Sponsors and Collaborators
Instituto de Cardiologia de Santa Catarina
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Responsible Party: Daniel Medeiros Moreira, Clinical vice-director, Instituto de Cardiologia de Santa Catarina
ClinicalTrials.gov Identifier: NCT03015064    
Other Study ID Numbers: CAAE: 55450816.0.1001.0113
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases