Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP|
- 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 ]
- survival rate [ Time Frame: 2.7years (median follow-up) ]
- cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization) [ Time Frame: 2.7years (median follow-up) ]
- reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain) [ Time Frame: 24hrs ]
- the association of SNPs of ANP-related genes with response to ANP treatment [ Time Frame: 2.7years (median follow-up) ]
|Study Start Date:||October 2001|
|Study Completion Date:||December 2005|
|Active Comparator: ANP||
0∙025 μg/kg per min for 3 days(intravenous)
|Placebo Comparator: Control||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212056
|National Cardiovascular Center|
|Suita, Osaka, Japan, 544-0024|
|Study Chair:||Masafumi Kitakaze, MD, PhD||National Cerebral and Cardiovascular Center|