- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04088682
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Studieoversikt
Status
Forhold
Intervensjon / Behandling
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
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-post: wanghongjianfw@hotmail.com
Studer Kontakt Backup
- Navn: Kefei Dou
- Telefonnummer: 13801032912
- E-post: drdoukefei@126.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Rekruttering
- Hongjian Wang
-
Ta kontakt med:
- Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-post: wanghongjianfw@hotmail.com
-
Ta kontakt med:
- Yin Dong
- Telefonnummer: 13552582795
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria:
- None
Studieplan
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
Etterforskere
- Hovedetterforsker: Zhe Zheng, Fuwai Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCCQI-CAD
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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