Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Overview
- Phase
- Phase 4
- Intervention
- Nicorandil
- Conditions
- Myocardial Infarction
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Infarct size as measured by cardiac MRI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI
Detailed Description
The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.
Investigators
Yun Dai Chen
Professor
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •Acute ST-T elevation MI patients (\<12h)
- •undergoing emergency PCI；
- •Subject has read and signed a written, informed consent form.
Exclusion Criteria
- •SBP\<80mmHg；
- •LM stenosis
- •Aortic dissection；
- •AMI (\<6 month)
- •PCI或CABG (\<6 month)
- •Already under the treatment of Nicorandil；
- •Contraindicated or intolerable to Nicorandil
- •severe adverse effects to CMR or MRI；
- •Currently (or within one month) participating in another new drug trial.；
- •Pregnant or lactation period；
Arms & Interventions
Treatment arm
Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group);
Intervention: Nicorandil
Placebo arm
Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
Intervention: Placebo
Outcomes
Primary Outcomes
Infarct size as measured by cardiac MRI
Time Frame: 7 days after primary PCI
The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians.
Secondary Outcomes
- Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)(5 minutes after stent implantation during PCI)
- Incidence of slow flow/no-reflow(5 minutes after stent implantation during PCI)
- CIN(48-72 hours after primary PCI)
- Infarct size as measured by cardiac MRI(6 months after PCI)
- Serum creatinine kinase (CK-MB) level(Baseline, 6, 12, 18, 24 hours after the PCI)
- Microvascular obstructionmeasured by cardiac MRI(7 days after the procedure)
- MACE(up to 12 months)
- ST-segment fall rate of electrocardiogram (ECG)(2 hours after the procedure)
- Edema size (LV area %) measured by cardiac MRI(7 days after the procedure)
- LV Ejection fraction (%) as measured by cardiac MRI(6 months after the procedure)