NCT04996901

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,594

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 22, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

July 27, 2021

Last Update Submit

December 9, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • in-hospital acute de novo heart failure

    Killip class ≥II

    in-hospital outcome, until discharge

  • cardiogenic shock

    according to the universal definition

    in-hospital outcome, until discharge

  • death

    according to the universal definition

    in-hospital outcome, until discharge

Study Arms (2)

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

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

Interventions

no intervention

derivation cohortvalidation cohort

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location

Related Publications (4)

  • Xu J, Luo D, Lei Y, Hu Z, Tian H, Chen X, Zhou W, Li M, Liu S, Jin X, Wang Y, Zhang B, Zhou Q, Chen J. Correlation between abnormal microvascular perfusion and quantitative flow ratio after primary PCI in patients with STEMI. Int J Cardiol. 2025 Mar 1;422:132949. doi: 10.1016/j.ijcard.2024.132949. Epub 2024 Dec 31.

  • Wang H, Yang Y, Zeng P, Huang R, Cai X, Shao L, Liu F, Lei Y, Li D, Fan Z, Yang J, Zhang J, Yang J. Association between Systemic Immune-Inflammation Index (SII) and New-Onset In-Hospital Heart Failure in Patients with STEMI after Primary PCI. Rev Cardiovasc Med. 2024 Oct 24;25(10):382. doi: 10.31083/j.rcm2510382. eCollection 2024 Oct.

  • Hu Z, Luo D, Zhou WJ, Xu CW, Chen XZ, Zhang BF, Jin X, Wang Y, Zhang J, Wu H, Liu FY, Lei YH, Li DS, Cai XY, Jiang H, Chen J. Association between admission blood pressure and spontaneous reperfusion and long-term prognosis in STEMI patients: an observational and multicenter study. BMC Cardiovasc Disord. 2024 Sep 18;24(1):500. doi: 10.1186/s12872-024-04168-4.

  • Luo D, Huang R, Wang X, Zhang J, Cai X, Liu F, Lei Y, Li D, Zhou W, Xu C, Huang B, Jiang H, Chen J. INTRA-AORTIC BALLOON PUMP REDUCES 30-DAY MORTALITY IN EARLY-STAGE CARDIOGENIC SHOCK COMPLICATING ACUTE MYOCARDIAL INFARCTION ACCORDING TO SCAI CLASSIFICATION. Shock. 2023 Sep 1;60(3):385-391. doi: 10.1097/SHK.0000000000002184. Epub 2023 Aug 4.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Liwei Cheng

    Renmin Hospital of Wuhan University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 9, 2021

Study Start

May 22, 2021

Primary Completion

December 5, 2021

Study Completion

December 5, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations