- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04088682
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-mail: wanghongjianfw@hotmail.com
Undersøgelse Kontakt Backup
- Navn: Kefei Dou
- Telefonnummer: 13801032912
- E-mail: drdoukefei@126.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Rekruttering
- Hongjian Wang
-
Kontakt:
- Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-mail: wanghongjianfw@hotmail.com
-
Kontakt:
- Yin Dong
- Telefonnummer: 13552582795
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
|
Reperfusionsbehandlingshastighed
Tidsramme: 24 timer efter indlæggelsen
|
Reperfusionsbehandlingshastighed er defineret som udnyttelsesgrad af trombolytisk terapi eller primær PCI-behandling blandt patienter, der er indiceret med reperfusionsterapi.
|
24 timer efter indlæggelsen
|
|
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 af trombolytisk terapi
Tidsramme: 24 timer efter indlæggelsen
|
Andelen af dør-til-nål-tid (D2N) inden for 30 minutter blandt alle patienter, der får fibrinolytisk behandling.
|
24 timer efter indlæggelsen
|
|
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)
|
|
Brug af β-blokkere under indlæggelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af β-blokkere, der anvendes under indlæggelse blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
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 bruges under indlæggelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af statiner, der bruges under indlæggelse blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
Aspirinbrug ved udskrivelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af aspirinbrug ved udskrivelse blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
Clopidogrel (eller ticagrelor) anvendes ved udskrivelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af Clopidogrel (eller ticagrelor) brug ved udskrivelse blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
β-blokkere anvendes ved udskrivelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af β-blokkere, der anvendes ved udskrivelse blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
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 bruges ved udskrivelse
Tidsramme: 10 dage i gennemsnit (under indlæggelse)
|
Andel af statiner, der bruges ved udskrivelsen blandt kvalificerede patienter.
|
10 dage i gennemsnit (under indlæggelse)
|
|
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)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Zhe Zheng, Fuwai Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCCQI-CAD
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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