Myocardial Infarction, Nicorandil, Percutaneous Coronary Intervention
Conditions
Keywords
Cardiac magnetic resonance; Infarct Size
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.
Interventions
DRUGNicorandil
After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h
OTHERPlacebo
After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h
Sponsors
First People's Hospital of Yulin
Beijing Chao Yang Hospital
Wuhan Asia Heart Hospital
Hainan Hospital of PLA General Hospital
Zunyi Medical College
Guizhou Provincial People's Hospital
Second Affiliated Hospital of Nanchang University
The Second Hospital of Hebei Medical University
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Acute ST-T elevation MI patients (\<12h) 2. undergoing emergency PCI； 3. Subject has read and signed a written, informed consent form.
Exclusion criteria
1. SBP\<80mmHg； 2. LM stenosis 3. Aortic dissection； 4. AMI (\<6 month) 5. PCI或CABG (\<6 month) 6. Already under the treatment of Nicorandil； 7. Contraindicated or intolerable to Nicorandil 8. severe adverse effects to CMR or MRI； 9. Currently (or within one month) participating in another new drug trial.； 10. Pregnant or lactation period； 11. Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size as measured by cardiac MRI | 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
| Measure | Time frame | Description |
|---|---|---|
| Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) | 5 minutes after stent implantation during PCI | the starting point is the number of frames in which the contrast agent completely or nearly completely filled the beginning of the coronary artery and touched both sides of the coronary vessel wall, and the end point is the number of frames in which the contrast agent entered the distal branch vessel and developed a specific anatomical marker |
| Incidence of slow flow/no-reflow | 5 minutes after stent implantation during PCI | When scanning at a rate of 15 frames per second, cTFC \> 27 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI |
| ST-segment fall rate of electrocardiogram (ECG) | 2 hours after the procedure | Complete ST-segment resolution at 2 h after PCI |
| Serum creatinine kinase (CK-MB) level | Baseline, 6, 12, 18, 24 hours after the PCI | Change of serum creatinine kinase |
| Infarct size as measured by cardiac MRI | 6 months after PCI | The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images. |
| Microvascular obstructionmeasured by cardiac MRI | 7 days after the procedure | Microvascular obstructionmeasured |
| LV Ejection fraction (%) as measured by cardiac MRI | 7 days after the procedure | LV Ejection fraction in early phase |
| MACE | up to 12 months | all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI |
| CIN | 48-72 hours after primary PCI | contrast induced nephropathy |
| Edema size (LV area %) measured by cardiac MRI | 7 days after the procedure | Edema size |
Countries
China
Outcome results
None listed