NCT04088682

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jul 2018Dec 2035

Study Start

First participant enrolled

July 15, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

17.5 years

First QC Date

September 9, 2019

Last Update Submit

October 8, 2019

Conditions

Keywords

clinical performancequality measuresST-Elevation myocardial infarction

Outcome Measures

Primary Outcomes (31)

  • Aspirin at arrival

    Proportion of aspirin use within 24 hours of admission among eligible patients

    24 hours after admission

  • Clopidogrel (or ticagrelor) at arrival

    Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients

    24 hours after admission

  • β-blockers at arrival

    Proportion of β-blockers use within 24 hours of admission among eligible patients

    24 hours after admission

  • ECG at arrival

    Proportion of ECG test within 10 minutes of admission among eligible patients

    24 hours after admission

  • Reperfusion therapy rate

    Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.

    24 hours after admission

  • Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)

    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)

    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)

  • Timeliness of thrombolytic therapy

    The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.

    24 hours after admission

  • Timeliness of primary PCI

    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

    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

    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

    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

    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

    Proportion of Aspirin use during hospitalization among eligible patients.

    10 days on average (during hospitalization)

  • Clopidogrel (or ticagrelor) use during hospitalization

    Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.

    10 days on average (during hospitalization)

  • β-blockers use during hospitalization

    Proportion of β-blockers use during hospitalization among eligible patients.

    10 days on average (during hospitalization)

  • Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization

    Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.

    10 days on average (during hospitalization)

  • Statins use during hospitalization

    Proportion of statins use during hospitalization among eligible patients.

    10 days on average (during hospitalization)

  • Aspirin use at discharge

    Proportion of aspirin use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • Clopidogrel (or ticagrelor) use at discharge

    Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • β-blockers use at discharge

    Proportion of β-blockers use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge

    Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • Statins use at discharge

    Proportion of statins use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • Aldosterone Antagonist at Discharge

    Proportion of Aldosterone Antagonist use at discharge among eligible patients.

    10 days on average (during hospitalization)

  • Smoking cessation advice/ counseling at Discharge

    Proportion of patients received smoking cessation advice/ counseling

    10 days on average (during hospitalization)

  • all-cause mortality during hospitalization

    Proportion of patients who were all-cause death during hospitalization

    10 days on average (during hospitalization)

  • Cardiac mortality during hospitalization

    Proportion of patients who were cardiac death during hospitalization

    10 days on average (during hospitalization)

  • 30-day all-cause mortality

    Proportion of patients who were all-cause death from admission to 30days

    From admission to 30days

  • 30-day cardiac mortality

    Proportion of patients who were cardiac death from admission to 30days

    From admission to 30days

  • 30-day readmission rates

    Proportion of patients readmission from hospital discharge to 30days

    From hospital discharge to 30 days

  • Cost during hospitalization

    Cost during hospitalization

    10 days on average (during hospitalization)

Study Arms (1)

All hospitals

All hospitals will take the treatment quality improvement strategies and tools into implementation. Intervention: Behavioral: Quality improvement strategies and tools

Behavioral: Quality improvement strategies and tools

Interventions

Quality improvement strategies and tools

All hospitals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongjian Wang

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Zhe Zheng

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 13, 2019

Study Start

July 15, 2018

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

October 9, 2019

Record last verified: 2019-09

Locations