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Sponsors and Collaborators: |
National Cardiovascular Center, Japan Japan Cardiovascular Reserch Foundation |
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Information provided by: | National Cardiovascular Center, Japan |
ClinicalTrials.gov Identifier: | NCT00212056 |
To evaluate whether ANP as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.
Condition | Intervention |
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Acute Myocardial Infarction |
Drug: ANP(hANP) Drug: Control |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP |
Estimated Enrollment: | 600 |
Study Start Date: | October 2001 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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ANP: Active Comparator |
Drug: ANP(hANP)
0∙025 μg/kg per min for 3 days(intravenous)
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Control: Placebo Comparator |
Drug: Control
placebo
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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.
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, OSAKA | |
National Cardiovascular Center | |
Suita, OSAKA, Japan, 544-0024 |
Study Chair: | Masafumi Kitakaze, MD, PhD | National Cardiovascular Center |
Study ID Numbers: | CSSCJ-1, UMIN_ID:C000000088 |
Study First Received: | September 13, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00212056 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Acute myocardial infarction Atrial natriuretic peptide Data mining Randomized clinical trial SNPs |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |