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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03939338

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted June 26, 2019

Study Description

Brief summary:

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).

  • Condition or Disease:STEMI - ST Elevation Myocardial Infarction
    Reperfusion Injury, Myocardial
  • Intervention/Treatment: Other: Treg levels and CMR results
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 250 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: 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)
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: August 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Participates
Other: Treg levels and CMR results
This is an observational study. Exposure: Different Treg levels and CMR results.
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
Criteria

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

Contacts and Locations
Contacts

Contact: Hongwei Li, M.D. 0086 10 63139780 lhw19656@sina.com

Locations

China, Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing

Sponsors and Collaborators

Beijing Friendship Hospital

More Information
  • Responsible Party: Beijing Friendship Hospital
  • ClinicalTrials.gov Identifier: NCT03939338 History of Changes
  • Other Study ID Numbers: BFH-Treg and CMR
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: June 26, 2019
  • Last Verified: June 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Myocardial Infarction
    ST Elevation Myocardial Infarction
    Reperfusion Injury
    Myocardial Reperfusion Injury
    Infarction
    Wounds and Injuries