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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03939338
Other study ID # BFH-Treg and CMR
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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