China-Administration of Nicorandil Group（CHANGE）

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
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Myocardial Infarction, Percutaneous Coronary Intervention, Nicorandil

Intervention / Treatment
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* Drug: Nicorandil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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； 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>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); | Drug: Nicorandil<br>* 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<br>|
| Placebo Comparator: Placebo arm<br>Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI. | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size as measured by cardiac MRI | 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. | 7 days after primary PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size as measured by cardiac MRI | The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images. | 6 months after PCI | 
| Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) | 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 | 5 minutes after stent implantation during PCI | 
| Incidence of slow flow/no-reflow | 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 | 5 minutes after stent implantation during PCI | 
| ST-segment fall rate of electrocardiogram (ECG) | Complete ST-segment resolution at 2 h after PCI | 2 hours after the procedure | 
| Serum creatinine kinase (CK-MB) level | Change of serum creatinine kinase | Baseline, 6, 12, 18, 24 hours after the PCI | 
| Edema size (LV area %) measured by cardiac MRI | Edema size | 7 days after the procedure | 
| Microvascular obstructionmeasured by cardiac MRI | Microvascular obstructionmeasured | 7 days after the procedure | 
| LV Ejection fraction (%) as measured by cardiac MRI | LV Ejection fraction in early phase | 7 days after the procedure | 
| LV Ejection fraction (%) as measured by cardiac MRI | LV Ejection fraction in late phase | 6 months after the procedure | 
| MACE | all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI | up to 12 months | 
| CIN | contrast induced nephropathy | 48-72 hours after primary PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac magnetic resonance; Infarct Size