NCT03510832

Brief Summary

EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. Novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than 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

March 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

March 20, 2018

Last Update Submit

April 26, 2018

Conditions

STEMIEmergent PCI

Outcome Measures

Primary Outcomes (1)

  • Net Adverse Clinical Events (NACEs)

    The primary outcome is the rate of adjudicated NACEs, a composite of major adverse cardiac or cerebral events (MACCEs) and bleeding. MACCEs include cardiac death, reinfarction, urgent revascularization, or stroke. Bleeding is defined by the Bleeding Academic Research Consortium (BARC) definition (types 1-5). BARC type 2 bleeding is considered as minor bleeding, type 3-5 bleeding is considered as major bleeding.

    2 years after emergent PCI

Secondary Outcomes (4)

  • Contrast-induced acute kidney injury (CI-AKI)

    72 hours after contrast exposure

  • Definite/Probable Stent thrombosis

    2 years after emergent PCI

  • Heart failure

    2 years after emergent PCI

  • Quality of life (QoL)

    2 years after emergent PCI

Study Arms (1)

STEMI patients undergoing Emergent PCI

Eligibility Criteria

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

consecutive STEMI patients undergoing emergent PCI

You may qualify if:

  • Age\>=18yrs
  • STEMI patients undergoing emergent PCI
  • Signed informed consent

You may not qualify if:

  • Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
  • Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yuguo Chen, Dr

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 27, 2018

Study Start

March 1, 2018

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

April 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)