Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study (Catarina)
6 janvier 2017 mis à jour par: Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
Post-Myocardial Infarction Patients in Santa Catarina, Brazil: a Prospective Cohort Study - 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Anticipé)
1426
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Santa Catarina
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São José, Santa Catarina, Brésil
- Instituto de Cardiologia de Santa Catarina
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Myocardial Infarction
Patients with first myocardial Infarction
|
Observational study of myocardial Infarction patients
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
MACE in 1 year
Délai: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
|
Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year
|
|
MACE in 30 days
Délai: Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
|
Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days
|
|
Death in 1 year
Délai: Death incidence in 1 year
|
Death incidence in 1 year
|
|
Death in 30 days
Délai: Death incidence in 30 days
|
Death incidence in 30 days
|
|
Restenosis in 1 year
Délai: Restenosis incidence in 1 year
|
Restenosis incidence in 1 year
|
|
Restenosis in 30 days
Délai: Restenosis incidence in 30 days
|
Restenosis incidence in 30 days
|
|
Intrastent thrombosis in 1 year
Délai: Intrastent thrombosis incidence in 30 days
|
Intrastent thrombosis incidence in 30 days
|
|
Intrastent thrombosis in 30 days
Délai: Intrastent thrombosis incidence in 30 days
|
Intrastent thrombosis incidence in 30 days
|
|
Cardiovascular death in 1 year
Délai: Cardiovascular death incidence in 1 year
|
Cardiovascular death incidence in 1 year
|
|
Cardiovascular death in 30 days
Délai: Cardiovascular death incidence in 30 days
|
Cardiovascular death incidence in 30 days
|
|
Nonfatal infarction in 1 year
Délai: Nonfatal infarction incidence in 1 year
|
Nonfatal infarction incidence in 1 year
|
|
Nonfatal infarction in 30 days
Délai: Nonfatal infarction incidence in 30 days
|
Nonfatal infarction incidence in 30 days
|
|
Unstable angina in 1 year
Délai: Unstable angina incidence in 1 year
|
Unstable angina incidence in 1 year
|
|
Unstable angina in 30 days
Délai: Unstable angina incidence in 30 days
|
Unstable angina incidence in 30 days
|
|
Stroke in 1 year
Délai: Stroke incidence in 1 year
|
Stroke incidence in 1 year
|
|
Stroke in 30 days
Délai: Stroke incidence in 30 days
|
Stroke incidence in 30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Epidemiological profile
Délai: Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
|
Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission
|
|
|
Fish consumption
Délai: 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
|
Fish consumption at admission
|
|
Red meat consumption
Délai: 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
|
Red meat consumption at admission
|
|
Chocolate consumption
Délai: 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
|
Chocolate consumption at admission
|
|
Caffeine consumption
Délai: 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
|
Caffeine consumption at admission
|
|
Alcoholic beverages consumption
Délai: 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
|
Alcoholic beverages consumption at admission
|
|
Illegal drugs consumption
Délai: 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
|
Illegal drugs consumption at admission
|
|
Cognitive level
Délai: 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
|
Cognitive level at admission
|
|
Religiosity
Délai: 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
|
Religiosity at admission
|
|
Pre-infarct physical activity
Délai: 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
|
Pre-infarct physical activity at admission
|
|
Depression
Délai: 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
|
Depression at admission
|
|
Syntax score
Délai: 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
|
Syntax score at admission
|
|
TIMI frame count
Délai: 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
|
TIMI frame count in patients with primary angioplasty at admission
|
|
Ventricular function post-infarction
Délai: 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
|
Ventricular function post-infarction (evaluated within 72 hours of admission)
|
|
Hospitalization in 1 year
Délai: Hospitalization incidence in 1 year
|
Hospitalization incidence in 1 year
|
|
|
Hospitalization in 30 days
Délai: Hospitalization incidence in 30 days
|
Hospitalization incidence in 30 days
|
|
|
Bleeding in 1 year
Délai: Bleeding incidence in 1 year
|
Bleeding incidence in 1 year
|
|
|
Bleeding in 30 days
Délai: Bleeding incidence in 30 days
|
Bleeding incidence in 30 days
|
|
|
Hematocrit and hemoglobin
Délai: Hematocrit and hemoglobin at the admission
|
Hematocrit and hemoglobin at the admission
|
|
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Hematocrit and hemoglobin in 72 hours
Délai: Hematocrit and hemoglobin in 72 hours
|
Hematocrit and hemoglobin in 72 hours
|
|
|
Red Cell Distribution Width (RDW)
Délai: Red Cell Distribution Width (RDW) at admission
|
Red Cell Distribution Width (RDW) at admission
|
|
|
Red Cell Distribution Width (RDW)
Délai: Red Cell Distribution Width (RDW) in 72 hours
|
Red Cell Distribution Width (RDW) in 72 hours
|
|
|
Leukocytes
Délai: Leukocytes at admission
|
Leukocytes at admission
|
|
|
Leukocytes
Délai: Leukocytes in 72 hours
|
Leukocytes in 72 hours
|
|
|
Creatinine
Délai: Creatinine at admission
|
Creatinine at admission
|
|
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Creatinine
Délai: Creatinine in 72 hours
|
Creatinine in 72 hours
|
|
|
Troponin levels
Délai: Troponin levels at admission
|
Troponin levels at admission
|
|
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Troponin levels
Délai: Troponin levels in 72 hours
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Troponin levels in 72 hours
|
|
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Cholesterol levels
Délai: Cholesterol levels at admission
|
Cholesterol levels at admission
|
|
|
Cholesterol levels
Délai: Cholesterol levels in 72 hours
|
Cholesterol levels in 72 hours
|
|
|
C-reactive protein
Délai: C-reactive protein at admission
|
C-reactive protein at admission
|
|
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C-reactive protein
Délai: C-reactive protein in 72 hours
|
C-reactive protein in 72 hours
|
|
|
CHA2DS2-VASc Score
Délai: 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
|
CHA2DS2-VASc Score at admission
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2016
Achèvement primaire (Anticipé)
1 décembre 2020
Achèvement de l'étude (Anticipé)
1 décembre 2020
Dates d'inscription aux études
Première soumission
30 décembre 2016
Première soumission répondant aux critères de contrôle qualité
6 janvier 2017
Première publication (Estimation)
9 janvier 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 janvier 2017
Dernière vérification
1 janvier 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAAE: 55450816.0.1001.0113
Plan pour les données individuelles des participants (IPD)
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