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

• Conditions: Reperfusion Injury, Myocardial; STEMI - ST Elevation Myocardial Infarction
• Interventions: Other: Treg levels and CMR results

• Registration Number: NCT03939338
• Lead Sponsor: Beijing Friendship Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Study Start: 2019-07-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participates	Treg levels and CMR results	-

Primary Outcome Measures

Name	Time	Method
MACE (major adverse cardiovascular events)	12 months	nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China