Cardiovascular Diseases
Conditions
Brief 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.
Interventions
DRUGIvabradine
The starting dose is 5 mg twice a day. Adjust the dose according to the actual situation
Sponsors
Qian geng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarct size according to MR delayed enhancement scan | 7 days after PCI | Two experienced MRI cardiologists analyzed the delayed enhancement image enhancement area of MRI to obtain the area of myocardial infarction through the Segment v1.9 post-processing software |
| main cardiovascular events | follow up in 6 months | Acute heart failure, recurrence of myocardial infarction, death from all causes, stroke, cardiac death, recurrent myocardial infarction, recurrent target vascular revascularization, re-admission because of angina pectoris or heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of the LVEF | follow up in 6 months | left ventricular ejection fraction (LVEF) |
Countries
China
Outcome results
None listed