Combination With Treg Levels and CMR to Assess the Severity and Prognosis of Reperfusion Injury After PPCI in STEMI Patients (TregCMRRS)

June 25, 2019 updated by: Hongwei Li, MD, Beijing Friendship Hospital

Combination With Regulatory T Cell Levels and Cardiac Magnetic Resonance Imaging (CMR) to Assess the Severity and Prognosis of Reperfusion Injury After Primary PCI in STEMI Patients (TregCMRRS)

This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

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
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention

Description

Inclusion Criteria:

  • Confirmed STEMI diagnosis
  • Undergoing primary percutaneous coronary intervention (presenting <12 hours after symptom onset)
  • Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
  • Patients agreed and provided informed consent

Exclusion Criteria:

  • Previous myocardial infarction or revascularization (PCI or CABG)
  • Congestive heart failure with LVEF<40%
  • Atrial fibrillation
  • Renal insufficiency (GFR < 30 ml/min/1.73m^2)
  • Acute infectious diseases within nearly 3 months
  • Rheumatic immune system diseases
  • Malignant tumors
  • Claustrophobia
  • Contraindicated to CMR
  • Patients do not agree to be included in the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participates
Other: Treg levels and CMR results
This is an observational study. Exposure: Different Treg levels and CMR results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (major adverse cardiovascular events)
Time Frame: 12 months
nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse cardiac remodeling
Time Frame: 6 months
a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans
6 months

Collaborators and Investigators

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

Sponsor

Beijing Friendship 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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH-Treg and CMR

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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