- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04088682
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-post: wanghongjianfw@hotmail.com
Studera Kontakt Backup
- Namn: Kefei Dou
- Telefonnummer: 13801032912
- E-post: drdoukefei@126.com
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Rekrytering
- Hongjian Wang
-
Kontakt:
- Hongjian Wang
- Telefonnummer: 13910008985 13910008985
- E-post: wanghongjianfw@hotmail.com
-
Kontakt:
- Yin Dong
- Telefonnummer: 13552582795
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Aspirin at arrival
Tidsram: 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
Tidsram: 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
Tidsram: 24 hours after admission
|
Proportion of β-blockers use within 24 hours of admission among eligible patients
|
24 hours after admission
|
ECG at arrival
Tidsram: 24 hours after admission
|
Proportion of ECG test within 10 minutes of admission among eligible patients
|
24 hours after admission
|
Reperfusionsterapihastighet
Tidsram: 24 timmar efter intagningen
|
Reperfusionsterapihastighet definieras som utnyttjandegrad av trombolytisk terapi eller primär PCI-behandling bland patienter indikerade med reperfusionsterapi.
|
24 timmar efter intagningen
|
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
Tidsram: 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)
Tidsram: 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)
|
Aktuell trombolytisk terapi
Tidsram: 24 timmar efter intagningen
|
Andelen dörr till nål-tid (D2N) inom 30 minuter bland alla patienter som får fibrinolytisk behandling.
|
24 timmar efter intagningen
|
Timeliness of primary PCI
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 10 days on average (during hospitalization)
|
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
|
10 days on average (during hospitalization)
|
β-blockerare används under sjukhusvistelse
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel β-blockerare som används under sjukhusvistelse bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
Tidsram: 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 används under sjukhusvistelse
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel statiner som används under sjukhusvistelse bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
Aspirinanvändning vid utskrivning
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel acetylsalicylsyraanvändning vid utskrivning bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
Clopidogrel (eller ticagrelor) används vid utskrivning
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel användning av Clopidogrel (eller ticagrelor) vid utskrivning bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
β-blockerare används vid utskrivning
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel β-blockerare som används vid utskrivning bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
Tidsram: 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 används vid utskrivning
Tidsram: 10 dagar i genomsnitt (under sjukhusvistelse)
|
Andel statiner som används vid utskrivning bland berättigade patienter.
|
10 dagar i genomsnitt (under sjukhusvistelse)
|
Aldosterone Antagonist at Discharge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From admission to 30days
|
Proportion of patients who were all-cause death from admission to 30days
|
From admission to 30days
|
30-day cardiac mortality
Tidsram: From admission to 30days
|
Proportion of patients who were cardiac death from admission to 30days
|
From admission to 30days
|
30-day readmission rates
Tidsram: From hospital discharge to 30 days
|
Proportion of patients readmission from hospital discharge to 30days
|
From hospital discharge to 30 days
|
Cost during hospitalization
Tidsram: 10 days on average (during hospitalization)
|
Cost during hospitalization
|
10 days on average (during hospitalization)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Zhe Zheng, Fuwai Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCCQI-CAD
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