Clinical trial NCT00212056: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Official title: Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Atrial natriuretic peptide
Data mining
Randomized clinical trial
SNPs
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
Collaborators: name: Japan Cardiovascular Research Foundation
First posted: 2005-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 20-79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Exclusion 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

Primary outcomes:
measure: estimated infarct size
timeFrame: 72hrs
measure: left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
timeFrame: 2-8weeks and 6-12months
Secondary outcomes:
measure: survival rate
timeFrame: 2.7years (median follow-up)
measure: cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
timeFrame: 2.7years (median follow-up)
measure: reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
timeFrame: 24hrs
measure: the association of SNPs of ANP-related genes with response to ANP treatment
timeFrame: 2.7years (median follow-up)
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
Study officials:
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Masafumi Kitakaze, MD, PhD
role: STUDY_CHAIR
References:
citation: Minamino T, Jiyoong K, Asakura M, Shintani Y, Asanuma H, Kitakaze M; J-WIND Investigators. Rationale and design of a large-scale trial using nicorandil as an adjunct to percutaneous coronary intervention for ST-segment elevation acute myocardial infarction: Japan-Working groups of acute myocardial infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP). Circ J. 2004 Feb;68(2):101-6. doi: 10.1253/circj.68.101.