Effect of Nicorandil for the Patients of Acute ST Segment Elevation Myocardial Infarction
- Registration Number
- NCT02435797
- Lead Sponsor
- Xuzhou Central Hospital
- Brief Summary
To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.
- Detailed Description
Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and myocardial cellular apoptosis, etc.
Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.
The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury and left ventricle remodeling in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and worsening of chest pain.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Acute ST Segment Elevation Myocardial Infarction (ASTEMI) defined as typical chest pain lasting >30min within the previous 12 h, with a clear ST-segment elevation of >0.1millivolt(mV) in ≥2 contiguous electrocardiographic leads, and the value of troponin I(TNI) above the maximum peak in the normal range.
- Age20-80,All genders
- The first myocardial infarction, and there is no history of PCI therapy and coronary artery bypass grafting
- The infarct-related artery(IRA) is totally occlusive
- Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
- The time from myocardial infarction onset to reach the hospital is less than 12 hs
- Successful interventional treatment, the residual stenosis of IRA is less than 30% ,
- TIMI flow grade 3
- kidney dysfunction (creatinine >2 mg/dl),
- History of previous liver disease,
- Cardiogenic shock,
- History of myocardial infarction (MI)
- History of coronary artery bypass grafting
- History of allergic response to drugs
- Right ventricular infarction
- Severe hypovolemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal saline normal saline normal saline Nicorandil Nicorandil Nicorandil for injection
- Primary Outcome Measures
Name Time Method Primary composite endpoint (whether premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether severity of chest pain is aggravated,and number of episodes chest pain) 24hours The primary composite endpoint consisted of reperfusion-induced arrhythmia, worsening of chest pain, and no-reflow/slow reflow.
In perioperative period,we will observe whether the reperfusion-induced arrhythmia including atrial or ventricular premature beats,atrial or ventricular tachycardia, atrial or ventricular fibrillation, and atrioventricular block appears;whether the severity of chest pain is aggravated,and the number of episodes of chest pain will be recorded for patients who complains of chest pain that lasted for at least 30 min within the 24 h following onset of MI;Whether the phenomenon of no-reflow/slow reflow appears.No-reflow and slow flow are diagnosed when the thrombolysis in myocardial infarction(TIMI) flow grade is 2 or lower,despite successful PCI such as balloon angioplasty or stent insertion.
- Secondary Outcome Measures
Name Time Method the combined outcome of TIMI frame count (cTFC) of CAG and ST resolution (STR) of ECG 24hours The cTFC was measured according to the method of Gibson et al, to determine blood flow at the time of coronary angiography. The cine frame counts derived from the injection of contrast medium to the peripheral landmark were measured .
In order to evaluate STR, the total sum of the ST segments elevation from the J point to the point reached 20ms later was calculated from the 12-lead ECG recorded before the start of reperfusion, and 90 min after the completion of reperfusion. The rate of improvement in ST elevation was classified as "complete resolution" (70% or more improvement) and "no resolution" (\<70%).
Trial Locations
- Locations (1)
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China