<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015064</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 55450816.0.1001.0113</org_study_id>
    <nct_id>NCT03015064</nct_id>
  </id_info>
  <brief_title>Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study</brief_title>
  <acronym>Catarina</acronym>
  <official_title>Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - Catarina Heart Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia de Santa Catarina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia de Santa Catarina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the&#xD;
      diagnosis of the first acute myocardial infarction from July 2016 until December 2020.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MACE in 1 year</measure>
    <time_frame>Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MACE in 30 days</measure>
    <time_frame>Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death in 1 year</measure>
    <time_frame>Death incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death in 30 days</measure>
    <time_frame>Death incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Restenosis in 1 year</measure>
    <time_frame>Restenosis incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Restenosis in 30 days</measure>
    <time_frame>Restenosis incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrastent thrombosis in 1 year</measure>
    <time_frame>Intrastent thrombosis incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrastent thrombosis in 30 days</measure>
    <time_frame>Intrastent thrombosis incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular death in 1 year</measure>
    <time_frame>Cardiovascular death incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular death in 30 days</measure>
    <time_frame>Cardiovascular death incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Nonfatal infarction in 1 year</measure>
    <time_frame>Nonfatal infarction incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Nonfatal infarction in 30 days</measure>
    <time_frame>Nonfatal infarction incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Unstable angina in 1 year</measure>
    <time_frame>Unstable angina incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Unstable angina in 30 days</measure>
    <time_frame>Unstable angina incidence in 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke in 1 year</measure>
    <time_frame>Stroke incidence in 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke in 30 days</measure>
    <time_frame>Stroke incidence in 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidemiological profile</measure>
    <time_frame>Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fish consumption</measure>
    <time_frame>Fish consumption at admission</time_frame>
    <description>Fish consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red meat consumption</measure>
    <time_frame>Red meat consumption at admission</time_frame>
    <description>Read meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chocolate consumption</measure>
    <time_frame>Chocolate consumption at admission</time_frame>
    <description>Red meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caffeine consumption</measure>
    <time_frame>Caffeine consumption at admission</time_frame>
    <description>Caffeine consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcoholic beverages consumption</measure>
    <time_frame>Alcoholic beverages consumption at admission</time_frame>
    <description>Alcoholic beverages consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illegal drugs consumption</measure>
    <time_frame>Illegal drugs consumption at admission</time_frame>
    <description>Illegal drugs consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive level</measure>
    <time_frame>Cognitive level at admission</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Religiosity</measure>
    <time_frame>Religiosity at admission</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-infarct physical activity</measure>
    <time_frame>Pre-infarct physical activity at admission</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Depression at admission</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Syntax score</measure>
    <time_frame>Syntax score at admission</time_frame>
    <description>Syntax score at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI frame count</measure>
    <time_frame>TIMI frame count in patients with primary angioplasty at admission</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventricular function post-infarction</measure>
    <time_frame>Ventricular function post-infarction (evaluated within 72 hours of admission)</time_frame>
    <description>Ventricular function (ventricular ejection fraction), its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization in 1 year</measure>
    <time_frame>Hospitalization incidence in 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization in 30 days</measure>
    <time_frame>Hospitalization incidence in 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding in 1 year</measure>
    <time_frame>Bleeding incidence in 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding in 30 days</measure>
    <time_frame>Bleeding incidence in 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit and hemoglobin</measure>
    <time_frame>Hematocrit and hemoglobin at the admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit and hemoglobin in 72 hours</measure>
    <time_frame>Hematocrit and hemoglobin in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Cell Distribution Width (RDW)</measure>
    <time_frame>Red Cell Distribution Width (RDW) at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Cell Distribution Width (RDW)</measure>
    <time_frame>Red Cell Distribution Width (RDW) in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocytes</measure>
    <time_frame>Leukocytes at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocytes</measure>
    <time_frame>Leukocytes in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Creatinine at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Creatinine in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin levels</measure>
    <time_frame>Troponin levels at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin levels</measure>
    <time_frame>Troponin levels in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol levels</measure>
    <time_frame>Cholesterol levels at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol levels</measure>
    <time_frame>Cholesterol levels in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>C-reactive protein at admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>C-reactive protein in 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHA2DS2-VASc Score</measure>
    <time_frame>CHA2DS2-VASc Score at admission</time_frame>
    <description>CHA2DS2-VASc Score, its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1426</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Myocardial Infarction</arm_group_label>
    <description>Patients with first myocardial Infarction</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myocardial Infarction</intervention_name>
    <description>Observational study of myocardial Infarction patients</description>
    <arm_group_label>Myocardial Infarction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients attended at the Santa Catarina Institute of Cardiology and other&#xD;
        hospitals in the State of Santa Catarina with the diagnosis of the first acute myocardial&#xD;
        infarction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years;&#xD;
&#xD;
          -  Presence of precordial pain suggestive of acute myocardial infarction associated with&#xD;
             electrocardiogram with new ST segment elevation in two contiguous leads with limits:&#xD;
             ≥0.1 mv in all leads other than leads V2-V3 where the following limits apply : ≥0.2 mv&#xD;
             in Men ≥40 years; ≥0.25 mV in men &lt;40 years, or ≥ 0.15 mV in women or presence of&#xD;
             precordial pain suggestive of acute myocardial infarction associated with elevation of&#xD;
             troponin I or CK-MB above the 99th percentile of the upper reference limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous acute myocardial infarction;&#xD;
&#xD;
          -  Disagreement with the Terms of Informed Consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto de Cardiologia de Santa Catarina</name>
      <address>
        <city>São José</city>
        <state>Santa Catarina</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Cardiologia de Santa Catarina</investigator_affiliation>
    <investigator_full_name>Daniel Medeiros Moreira</investigator_full_name>
    <investigator_title>Clinical vice-director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015064
org study id: CAAE: 55450816.0.1001.0113
nct id: NCT03015064
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: MACE in 1 year
time frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
measure: MACE in 30 days
time frame: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
measure: Death in 1 year
time frame: Death incidence in 1 year
measure: Death in 30 days
time frame: Death incidence in 30 days
measure: Restenosis in 1 year
time frame: Restenosis incidence in 1 year
measure: Restenosis in 30 days
time frame: Restenosis incidence in 30 days
measure: Intrastent thrombosis in 1 year
time frame: Intrastent thrombosis incidence in 30 days
measure: Intrastent thrombosis in 30 days
time frame: Intrastent thrombosis incidence in 30 days
measure: Cardiovascular death in 1 year
time frame: Cardiovascular death incidence in 1 year
measure: Cardiovascular death in 30 days
time frame: Cardiovascular death incidence in 30 days
measure: Nonfatal infarction in 1 year
time frame: Nonfatal infarction incidence in 1 year
measure: Nonfatal infarction in 30 days
time frame: Nonfatal infarction incidence in 30 days
measure: Unstable angina in 1 year
time frame: Unstable angina incidence in 1 year
measure: Unstable angina in 30 days
time frame: Unstable angina incidence in 30 days
measure: Stroke in 1 year
time frame: Stroke incidence in 1 year
measure: Stroke in 30 days
time frame: Stroke incidence in 30 days
measure: Epidemiological profile
time frame: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
measure: Fish consumption
time frame: Fish consumption at admission
description: Fish consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Red meat consumption
time frame: Red meat consumption at admission
description: Read meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Chocolate consumption
time frame: Chocolate consumption at admission
description: Red meat consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Caffeine consumption
time frame: Caffeine consumption at admission
description: Caffeine consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Alcoholic beverages consumption
time frame: Alcoholic beverages consumption at admission
description: Alcoholic beverages consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Illegal drugs consumption
time frame: Illegal drugs consumption at admission
description: Illegal drugs consumption at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Cognitive level
time frame: Cognitive level at admission
description: 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
measure: Religiosity
time frame: Religiosity at admission
description: 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
measure: Pre-infarct physical activity
time frame: Pre-infarct physical activity at admission
description: 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
measure: Depression
time frame: Depression at admission
description: 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
measure: Syntax score
time frame: Syntax score at admission
description: Syntax score at admission and its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: TIMI frame count
time frame: TIMI frame count in patients with primary angioplasty at admission
description: 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
measure: Ventricular function post-infarction
time frame: Ventricular function post-infarction (evaluated within 72 hours of admission)
description: Ventricular function (ventricular ejection fraction), its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
measure: Hospitalization in 1 year
time frame: Hospitalization incidence in 1 year
measure: Hospitalization in 30 days
time frame: Hospitalization incidence in 30 days
measure: Bleeding in 1 year
time frame: Bleeding incidence in 1 year
measure: Bleeding in 30 days
time frame: Bleeding incidence in 30 days
measure: Hematocrit and hemoglobin
time frame: Hematocrit and hemoglobin at the admission
measure: Hematocrit and hemoglobin in 72 hours
time frame: Hematocrit and hemoglobin in 72 hours
measure: Red Cell Distribution Width (RDW)
time frame: Red Cell Distribution Width (RDW) at admission
measure: Red Cell Distribution Width (RDW)
time frame: Red Cell Distribution Width (RDW) in 72 hours
measure: Leukocytes
time frame: Leukocytes at admission
measure: Leukocytes
time frame: Leukocytes in 72 hours
measure: Creatinine
time frame: Creatinine at admission
measure: Creatinine
time frame: Creatinine in 72 hours
measure: Troponin levels
time frame: Troponin levels at admission
measure: Troponin levels
time frame: Troponin levels in 72 hours
measure: Cholesterol levels
time frame: Cholesterol levels at admission
measure: Cholesterol levels
time frame: Cholesterol levels in 72 hours
measure: C-reactive protein
time frame: C-reactive protein at admission
measure: C-reactive protein
time frame: C-reactive protein in 72 hours
measure: CHA2DS2-VASc Score
time frame: CHA2DS2-VASc Score at admission
description: CHA2DS2-VASc Score, its correlation with other evaluated parameters and its association with death, hospitalization, stroke, acute coronary syndromes and infarction
arm group label: Myocardial Infarction
description: Patients with first myocardial Infarction
intervention type: Other
intervention name: Myocardial Infarction
description: Observational study of myocardial Infarction patients
arm group label: Myocardial Infarction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto de Cardiologia de Santa Catarina
investigator full name: Daniel Medeiros Moreira
investigator title: Clinical vice-director
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No