Shanghai ST-segment Elevation Myocardial Infarction Cohort

July 6, 2022 updated by: RUIYAN ZHANG, Ruijin Hospital

A Prospective Multicentre Cohort Study of Acute ST-segment Elevation Myocardial Infarction

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is a prospective cohort study. It aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
          • Shuo Feng, M.D., Ph.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Yangpu District Central Hospital
        • Contact:
          • Qunlin Gong, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Fengxian District Central Hospital
        • Contact:
          • Li Zhang, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Minhang District Central Hospital
        • Contact:
          • Jian Dong, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Fifth People's Hospital, Fudan University
        • Contact:
          • Qi Qiao, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Jiading District Central Hospital
        • Contact:
          • Chunya Zhang, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Putuo District Central Hospital
        • Contact:
          • Youlong Xu, M.D.

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 0-1 year
Major adverse cardiovascular events(MACE) in one year follow-up
0-1 year
Left Ventricular Function
Time Frame: 1 month, 6month and 1 year
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
Time Frame: 1 year
The pathological changes in culprit vessels in 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Synchronized analysis of phonocardiogram and electrocardiogram
Time Frame: 1 day, 1 month, 6 months, 1 year
Synchronized PCG and ECG data using a wearable cardiac monitoring patch
1 day, 1 month, 6 months, 1 year

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: 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., Shanghai Fifth People's Hospital,Fudan University
  • Study Chair: Wei Hu, Shanghai Minhang District Central Hospital
  • Study Chair: Yimeng Zhou, Shanghai Yangpu District Central Hospital
  • 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 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)

September 12, 2018

Primary Completion (Anticipated)

September 17, 2023

Study Completion (Anticipated)

September 17, 2024

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-STEMI

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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