The Chinese STEMI PPCI Registry (CSPR)

December 9, 2021 updated by: Renmin Hospital of Wuhan University

The Chinese ST-Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Registry

The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.

Study Type

Observational

Enrollment (Actual)

5594

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Renmin Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with STEMI were treated by primary percutaneous coronary intervention at 7 large centers from central China.

Description

Inclusion Criteria:

  1. Age≥18
  2. ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction
  3. STEMI treated by pPCI

Exclusion Criteria:

  1. Patient with heart failure in admission
  2. STEMI with symptom-onset-to-balloon time>24h
  3. pPCI was not successful or only underwent coronary angiography
  4. Killip class ≥II in admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
derivation cohort
Data from Renmin Hospital of Wuhan University, The First College of Clinical Medical Science, China Three Gorges University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital，and Wuhan Third Hospital will be used as a derivation cohort.
Other: no intervention
no intervention
validation cohort
Data from The First Affiliated Hospital of Dalian Medical University and Jiangxi Provincial People's Hopital will be used as a derivation cohort.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital acute de novo heart failure
Time Frame: in-hospital outcome, until discharge
Killip class ≥II
in-hospital outcome, until discharge
cardiogenic shock
Time Frame: in-hospital outcome, until discharge
according to the universal definition
in-hospital outcome, until discharge
death
Time Frame: in-hospital outcome, until discharge
according to the universal definition
in-hospital outcome, until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Collaborators

The First Affiliated Hospital of Dalian Medical University
Jiangxi Provincial People's Hopital
Wuhan Third Hospital
Xiangyang No.1 People's Hospital
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
The First College of Clinical Medical Science, China Three Gorges University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2021

Primary Completion (Actual)

December 5, 2021

Study Completion (Actual)

December 5, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 958374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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