Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Overview
- Phase
- Not Applicable
- Intervention
- ANP(hANP)
- Conditions
- Acute Myocardial Infarction
- Sponsor
- National Cerebral and Cardiovascular Center, Japan
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- estimated infarct size
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.
Detailed Description
The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, atrial natriuretic peptide (ANP) reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by ANP(J-WINDANP) designed a prospective, randomized, multicenter study, to evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion. Twenty hospitals in Japan will participate in the J-WIND-ANP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous ANP or placebo administration. The primary end-points are (1) estimated infarct size (Σcreatine kinase and troponin T) and (2) left ventricular function (left ventriculograms). Single nucleotide polymorphisms (SNPs) that may be associated with the function of ANP and susceptibility of AMI will be examined. Furthermore, a data mining method will be used to design the optimal combinational therapy for post-MI patients. J-WIND-ANP will provide important data on the effects of ANP as an adjunct to PCI for AMI and the SNPs information will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 20-79 years
- •Chest pain of more than 30 min
- •0.1 mV ST-segment elevation in 2 contiguous ECG leads
- •Admission to hospital within 12 h of symptom onset
- •First episode of AMI
- •Candidates for PCI
Exclusion Criteria
- •History of old myocardial infarction
- •Left main coronary artery stenosis
- •Severe liver and/or kidney dysfunction
- •Suspected aortic dissection
- •History of coronary artery bypass graft
- •History of allergic response to drugs
- •Severe hypovolemia
- •Right ventricular infarction
Arms & Interventions
ANP
Intervention: ANP(hANP)
Control
Intervention: Control
Outcomes
Primary Outcomes
estimated infarct size
Time Frame: 72hrs
left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
Time Frame: 2-8weeks and 6-12months
Secondary Outcomes
- survival rate(2.7years (median follow-up))
- the association of SNPs of ANP-related genes with response to ANP treatment(2.7years (median follow-up))
- cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)(2.7years (median follow-up))
- reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)(24hrs)