NCT03011879

Brief Summary

The program is to improve STEMI medical care quality in China. With the documents issued by National Health and Family Planning Commission of the People's Republic of China, the program was initialed in at least 200 primary PCI capable hospitals together with hundreds of adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30 patients will be enrolled consecutively from each PCI-capable center initially and from non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI capable hospitals will be enrolled and all of them will be followed up for 1 year. Key performance indicators (KPIs) in STEMI care will be collected using both national PCI online registry and a program STEMI online registry database for the purpose of improvement of medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each hospital after data analysis in each period. Comparison of every two cross-sectional data (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the improvement of medical quality.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

August 27, 2016

Last Update Submit

January 4, 2017

Conditions

ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (9)

  • Referfusion ratio in patients with symptom onset within 12 hours

    Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care

    12 hours

  • Door-to-ballnoon time in patients with symptom onset within 12 hours

    Door-to-ballnoon time is the key index to evaluate treatment of primary PCI

    12 hours

  • Door-to-needle time in patients with symptom onset within 12 hours

    Door-to-needle time is the key index to evaluate treatment of thrombolysis

    12 hours

  • Hospital admission via ambulance ratio

    2 years

  • Symptom onset to arrive in hospital

    2 years

  • Bypass ED ratio in patients with symptom onset within 12 hours

    12 hours

  • Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication

    DAPT means dual antiplatelet therapy

    3 yeras

  • In-hospital morbidity

    2 yeras

  • 1-year on time follow-up ratio

    1 year

Study Arms (3)

1.STEMI patients with symptom onset within 30 days

First round enrollment of STEMI patients with symptom onset within 30 days

Other: clinical pathway

2.STEMI patients with symptom onset within 30 days

Second round enrollment of STEMI patients with symptom onset within 30 days

Other: clinical pathway

3.STEMI patients with symptom onset within 30 days

Third round enrollment of STEMI patients with symptom onset within 30 days

Other: clinical pathway

Interventions

clinical pathwayOTHER
1.STEMI patients with symptom onset within 30 days2.STEMI patients with symptom onset within 30 days3.STEMI patients with symptom onset within 30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

STEMI patients with symptom onset within 30 days

You may qualify if:

  • STEMI patients with symptom onset within 30 days

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Peking University First Hospital

Beijing, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

patients under thrombolysis

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Yan Zhang, MD

CONTACT

8610-83575728drzhy1108@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Cardiology

Study Record Dates

First Submitted

August 27, 2016

First Posted

January 5, 2017

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)