Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

UMIN ID: C000000089

Registered date:31/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with AMI who are candidates for PCI(first episode of AMI)
• Date of first enrollment: 2001/10/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the nicorandil group, after a bolus injection of nicorandil(0.067 mg/kg), it is continuously infused intravenously at 1.67ug/kg·min for 24h.
In the control group, seline is continuously infused intravenously for 24h.

Outcome(s)

• Primary Outcome: (1) estimated infarct size and (2) left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion.
• Secondary Outcome: (1) survival rate (2)cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization) (3) reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain) (4) the association of SNPs of ANP-related genes with response to ANP treatment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1. History of old myocardial infarction 2. Left main coronary artery stenosis 3. Severe liver and/or kidney dysfunction 4. Suspected aortic dissection 5. History of coronary artery bypass graft 6. History of allergic response to drugs 7. Severe hypovolemia 8. Right ventricular infarction

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation