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

6. januar 2017 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Forventet)

1426

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
    • Santa Catarina
      • São José, Santa Catarina, Brasil
        • Instituto de Cardiologia de Santa Catarina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Myocardial Infarction
Patients with first myocardial Infarction
Annen: Myocardial Infarction
Observational study of myocardial Infarction patients

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
MACE in 1 year
Tidsramme: 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
Tidsramme: 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
Tidsramme: Death incidence in 1 year
Death incidence in 1 year
Death in 30 days
Tidsramme: Death incidence in 30 days
Death incidence in 30 days
Restenosis in 1 year
Tidsramme: Restenosis incidence in 1 year
Restenosis incidence in 1 year
Restenosis in 30 days
Tidsramme: Restenosis incidence in 30 days
Restenosis incidence in 30 days
Intrastent thrombosis in 1 year
Tidsramme: Intrastent thrombosis incidence in 30 days
Intrastent thrombosis incidence in 30 days
Intrastent thrombosis in 30 days
Tidsramme: Intrastent thrombosis incidence in 30 days
Intrastent thrombosis incidence in 30 days
Cardiovascular death in 1 year
Tidsramme: Cardiovascular death incidence in 1 year
Cardiovascular death incidence in 1 year
Cardiovascular death in 30 days
Tidsramme: Cardiovascular death incidence in 30 days
Cardiovascular death incidence in 30 days
Nonfatal infarction in 1 year
Tidsramme: Nonfatal infarction incidence in 1 year
Nonfatal infarction incidence in 1 year
Nonfatal infarction in 30 days
Tidsramme: Nonfatal infarction incidence in 30 days
Nonfatal infarction incidence in 30 days
Unstable angina in 1 year
Tidsramme: Unstable angina incidence in 1 year
Unstable angina incidence in 1 year
Unstable angina in 30 days
Tidsramme: Unstable angina incidence in 30 days
Unstable angina incidence in 30 days
Stroke in 1 year
Tidsramme: Stroke incidence in 1 year
Stroke incidence in 1 year
Stroke in 30 days
Tidsramme: Stroke incidence in 30 days
Stroke incidence in 30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Epidemiological profile
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Hospitalization incidence in 1 year
Hospitalization incidence in 1 year
Hospitalization in 30 days
Tidsramme: Hospitalization incidence in 30 days
Hospitalization incidence in 30 days
Bleeding in 1 year
Tidsramme: Bleeding incidence in 1 year
Bleeding incidence in 1 year
Bleeding in 30 days
Tidsramme: Bleeding incidence in 30 days
Bleeding incidence in 30 days
Hematocrit and hemoglobin
Tidsramme: Hematocrit and hemoglobin at the admission
Hematocrit and hemoglobin at the admission
Hematocrit and hemoglobin in 72 hours
Tidsramme: Hematocrit and hemoglobin in 72 hours
Hematocrit and hemoglobin in 72 hours
Red Cell Distribution Width (RDW)
Tidsramme: Red Cell Distribution Width (RDW) at admission
Red Cell Distribution Width (RDW) at admission
Red Cell Distribution Width (RDW)
Tidsramme: Red Cell Distribution Width (RDW) in 72 hours
Red Cell Distribution Width (RDW) in 72 hours
Leukocytes
Tidsramme: Leukocytes at admission
Leukocytes at admission
Leukocytes
Tidsramme: Leukocytes in 72 hours
Leukocytes in 72 hours
Creatinine
Tidsramme: Creatinine at admission
Creatinine at admission
Creatinine
Tidsramme: Creatinine in 72 hours
Creatinine in 72 hours
Troponin levels
Tidsramme: Troponin levels at admission
Troponin levels at admission
Troponin levels
Tidsramme: Troponin levels in 72 hours
Troponin levels in 72 hours
Cholesterol levels
Tidsramme: Cholesterol levels at admission
Cholesterol levels at admission
Cholesterol levels
Tidsramme: Cholesterol levels in 72 hours
Cholesterol levels in 72 hours
C-reactive protein
Tidsramme: C-reactive protein at admission
C-reactive protein at admission
C-reactive protein
Tidsramme: C-reactive protein in 72 hours
C-reactive protein in 72 hours
CHA2DS2-VASc Score
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Instituto de Cardiologia de Santa Catarina

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2016

Primær fullføring (Forventet)

1. desember 2020

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

30. desember 2016

Først innsendt som oppfylte QC-kriteriene

6. januar 2017

Først lagt ut (Anslag)

9. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CAAE: 55450816.0.1001.0113

Plan for individuelle deltakerdata (IPD)

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NEI

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