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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— TregCMRRS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939338
• Other study ID #: BFH-Treg and CMR
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2019
• Source: Beijing Friendship Hospital
• Contact: Hongwei Li, M.D.
• Phone: 0086 10 63139780
• Email: lhw19656[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Reperfusion Injury
• Reperfusion Injury
• Reperfusion Injury, Myocardial
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction
• Wounds and Injuries

Intervention

Other:
• Treg levels and CMR results
This is an observational study. Exposure: Different Treg levels and CMR results.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (major adverse cardiovascular events)	nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death	12 months
Secondary	adverse cardiac remodeling	a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans	6 months