NCT05450757

Brief Summary

ST-segment elevation myocardial infarction(STEMI) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (PCI),and standardized medical treatment.To improve the prognosis of STEMI patients, the management in their hospitalization should be optimized, including improvements in risk stratification, more widespread use of an invasive strategy, implementation of care delivery systems prioritising immediate revascularisation through PCI (or fibrinolysis), advances in antiplatelet agents and anticoagulants, and greater use of secondary prevention strategies such as lipid-lowering therapy. This study aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

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

September 12, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

July 2, 2022

Last Update Submit

July 6, 2022

Conditions

Keywords

Acute Myocardial InfarctionCardiac RemodellingHeart Failure

Outcome Measures

Primary Outcomes (3)

  • MACE

    Major adverse cardiovascular events(MACE) in one year follow-up

    0-1 year

  • Left Ventricular Function

    Left ventricular end diastolic volume(LVEDV),Left ventricular end systolic volume(LVESE),Left ventricular ejection fraction(LVEF) changes within one year follow-up

    1 month, 6month and 1 year

  • Coronary angiography

    The pathological changes in culprit vessels in 1 year

    1 year

Other Outcomes (1)

  • Synchronized analysis of phonocardiogram and electrocardiogram

    1 day, 1 month, 6 months, 1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is multi-center cohort study. Patients with acute ST elevation myocardial infarction undergo percutaneous coronary intervention within 12 hours of symptom onset at Ruijin Hospital, Minhang district Center Hospital, Yangpu district Center Hospital, Putuo district Center hospital,Jiading district Center Hospital, Fengxian district Center Hospital,and Shanghai Fifth people's Hospital, Shanghai, China are consecutively enrolled.

You may qualify if:

  • ST elevation myocardial infarction
  • Coronary angiography and percutaneous coronary intervention within 12 hours of symptom onset
  • Capable and willing to provide informed conset and capable of completing study visits

You may not qualify if:

  • Cardiovascular shock at admission
  • Severe physical disability
  • Active malignant tumors
  • Active autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Fengxian District Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Fifth People's Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Jiading District Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Putuo District Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Yangpu District Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples at the time of pre-PCI, post-PCI, post-PCI 1 day, post-PCI 3days

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionHeart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wei Wei Quan, M.D.,Ph.D.

    Ruijin Hospital

    STUDY CHAIR
  • Tian Qi Zhu, M.D.,Ph.D.

    Ruijin Hospital

    STUDY CHAIR
  • Xiao Xiang Yan, M.D.,Ph.D.

    Ruijin Hospital

    STUDY CHAIR
  • Wen Li Zhang, M.D.,Ph.D.

    Ruijin Hospital

    STUDY CHAIR
  • Run Du, M.D.,Ph.D.

    Ruijin Hospital

    STUDY CHAIR
  • Ying Jia Xu, M.D.,Ph.D.

    Fudan University

    STUDY CHAIR
  • Wei Hu

    Shanghai Minhang District Central Hospital

    STUDY CHAIR
  • Yimeng Zhou

    Tongji University

    STUDY CHAIR
  • Zongjun Liu

    Shanghai Putuo District Central Hospital

    STUDY CHAIR
  • Xiangdong Xu

    Shanghai Jiading District Central Hospital

    STUDY CHAIR
  • Zengyong Qiao

    Shanghai Fengxian District Central Hospital

    STUDY CHAIR

Central Study Contacts

Shuo Feng, M.D.,Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology Department, Chief Physician

Study Record Dates

First Submitted

July 2, 2022

First Posted

July 11, 2022

Study Start

September 12, 2018

Primary Completion

September 17, 2023

Study Completion

September 17, 2024

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations