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Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China

This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI. This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

Studieoversikt

Detaljert beskrivelse

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area.

This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI.

This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

New knowledge will be generated about STEMI management in China, to improve STEMI patients prognosis in future.

Studietype

Observasjonsmessig

Registrering (Forventet)

200000

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100037
        • Rekruttering
        • Hongjian Wang
        • Ta kontakt med:
        • Ta kontakt med:
          • Yin Dong
          • Telefonnummer: 13552582795

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

Sannsynlighetsprøve

Studiepopulasjon

Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset

Beskrivelse

Inclusion Criteria:

  • Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.

Exclusion Criteria:

  • None

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
All hospitals

All hospitals will take the treatment quality improvement strategies and tools into implementation.

Intervention: Behavioral: Quality improvement strategies and tools

Quality improvement strategies and tools

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Aspirin at arrival
Tidsramme: 24 hours after admission
Proportion of aspirin use within 24 hours of admission among eligible patients
24 hours after admission
Clopidogrel (or ticagrelor) at arrival
Tidsramme: 24 hours after admission
Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
24 hours after admission
β-blockers at arrival
Tidsramme: 24 hours after admission
Proportion of β-blockers use within 24 hours of admission among eligible patients
24 hours after admission
ECG at arrival
Tidsramme: 24 hours after admission
Proportion of ECG test within 10 minutes of admission among eligible patients
24 hours after admission
Frekvens for reperfusjonsbehandling
Tidsramme: 24 timer etter innleggelse
Reperfusjonsbehandlingsrate er definert som utnyttelsesgrad av trombolytisk terapi eller primær PCI-behandling blant pasienter indisert med reperfusjonsterapi.
24 timer etter innleggelse
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
Tidsramme: 10 days on average (during hospitalization)
The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.
10 days on average (during hospitalization)
Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
Tidsramme: 10 days on average (during hospitalization)
The proportion of from fibrinolysis to balloon (if fibrinolysis is successful) within 2-24hours among all patients receiving PCI.
10 days on average (during hospitalization)
Aktualitet av trombolytisk terapi
Tidsramme: 24 timer etter innleggelse
Andelen dør-til-nål-tid (D2N) innen 30 minutter blant alle pasienter som får fibrinolytisk behandling.
24 timer etter innleggelse
Timeliness of primary PCI
Tidsramme: 24 hours after admission
The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.
24 hours after admission
Door-in-Door-Out Time
Tidsramme: 24 hours after admission
Percentage of patients whose median time from the emergency department arrival at STEMI referral facility to emergency department discharge from STEMI referral facility is equal or less than 30 min. discharge from STEMI referral facility is 30 min.
24 hours after admission
Time to Primary PCI Among Transferred Patients
Tidsramme: 24 hours after admission
Percentage of patients whose median time from first medical contact (at or before emergency department arrival to the STEMI referral facility [e.g., non-PCI-capable facility]) to primary PCI at the STEMI receiving facility (PCI-capable facility) is equal or less than 120 min
24 hours after admission
Evaluation of LDL-C
Tidsramme: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization
10 days on average (during hospitalization)
Evaluation of left ventricular ejection fraction
Tidsramme: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization
10 days on average (during hospitalization)
Aspirin use during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Proportion of Aspirin use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
10 days on average (during hospitalization)
β-blokkere brukes under sykehusinnleggelse
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel bruk av β-blokkere under sykehusinnleggelse blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Statiner brukes under sykehusinnleggelse
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel statiner som brukes under sykehusinnleggelse blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
Aspirinbruk ved utskrivning
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel aspirinbruk ved utskrivning blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
Klopidogrel (eller ticagrelor) brukes ved utskrivning
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel bruk av Clopidogrel (eller ticagrelor) ved utskrivning blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
β-blokkere brukes ved utskrivning
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel bruk av β-blokkere ved utskrivning blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
Tidsramme: 10 days on average (during hospitalization)
Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
10 days on average (during hospitalization)
Statiner brukes ved utskrivning
Tidsramme: 10 dager i gjennomsnitt (under sykehusinnleggelse)
Andel bruk av statiner ved utskrivning blant kvalifiserte pasienter.
10 dager i gjennomsnitt (under sykehusinnleggelse)
Aldosterone Antagonist at Discharge
Tidsramme: 10 days on average (during hospitalization)
Proportion of Aldosterone Antagonist use at discharge among eligible patients.
10 days on average (during hospitalization)
Smoking cessation advice/ counseling at Discharge
Tidsramme: 10 days on average (during hospitalization)
Proportion of patients received smoking cessation advice/ counseling
10 days on average (during hospitalization)
all-cause mortality during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Proportion of patients who were all-cause death during hospitalization
10 days on average (during hospitalization)
Cardiac mortality during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Proportion of patients who were cardiac death during hospitalization
10 days on average (during hospitalization)
30-day all-cause mortality
Tidsramme: From admission to 30days
Proportion of patients who were all-cause death from admission to 30days
From admission to 30days
30-day cardiac mortality
Tidsramme: From admission to 30days
Proportion of patients who were cardiac death from admission to 30days
From admission to 30days
30-day readmission rates
Tidsramme: From hospital discharge to 30 days
Proportion of patients readmission from hospital discharge to 30days
From hospital discharge to 30 days
Cost during hospitalization
Tidsramme: 10 days on average (during hospitalization)
Cost during hospitalization
10 days on average (during hospitalization)

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Zhe Zheng, Fuwai Hospital

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 (Faktiske)

15. juli 2018

Primær fullføring (Forventet)

31. desember 2035

Studiet fullført (Forventet)

31. desember 2035

Datoer for studieregistrering

Først innsendt

9. september 2019

Først innsendt som oppfylte QC-kriteriene

12. september 2019

Først lagt ut (Faktiske)

13. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. oktober 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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