Clinical Study of CMR to Evaluate the Effect of Ivabradine on the Improvement of Left Ventricular Remodeling in STEMI Patients After Primary PCI

Qian geng

Status and phase: Unknown; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT05348057

qg-2021-12-01

Details and patient eligibility

About

This study aim to investigate the effect of ivabradine on reducing infarct size and improving left ventricular remodeling after in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Full description

Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between October 2020 and October 2021，the investigators randomly assign eligible patients in a 1:1 ratio to either ivabradine or oral placebo befor primary PCI. The treatment was initiated after primary PCI with ivabradine orally for 6 months. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). Cardiovascular events concluding stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
• patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion criteria

• had once treated by ivabradine
• history of myocardial infarction
• mechanical complications
• Unable to perform myocardial MRI
• liver and kidney failure
• malignant tumor
• unconscious

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Ivabradine group

Experimental group

Description:

The starting dose is 5 mg twice a day. After 2 weeks of treatment, if the patient's resting heart rate continues to be higher than 70 beats per minute, increase the dose to 7.5 mg twice a day. If the patient's resting heart rate continues to be less than 50 beats per minute or symptoms related to bradycardia occur, reduce the dose to 2.5 mg

Treatment:

Drug: Ivabradine

The control group

No Intervention group