NCT05348057

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Qian geng · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Ivabradine	The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-04-27
• Last updated: 2022-04-27

Locations

1 site across 1 country: China