Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ANP(hANP)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Atrial natriuretic peptide, Data mining, Randomized clinical trial, SNPs
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
Sites / Locations
- National Cardiovascular Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ANP
Control
Arm Description
Outcomes
Primary Outcome Measures
estimated infarct size
left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
Secondary Outcome Measures
survival rate
cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
the association of SNPs of ANP-related genes with response to ANP treatment
Full Information
NCT ID
NCT00212056
First Posted
September 13, 2005
Last Updated
October 31, 2007
Sponsor
National Cerebral and Cardiovascular Center, Japan
Collaborators
Japan Cardiovascular Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00212056
Brief Title
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
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Cerebral and Cardiovascular Center, Japan
Collaborators
Japan Cardiovascular Research Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Atrial natriuretic peptide, Data mining, Randomized clinical trial, SNPs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANP
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ANP(hANP)
Intervention Description
0∙025 μg/kg per min for 3 days(intravenous)
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
placebo
Primary Outcome Measure Information:
Title
estimated infarct size
Time Frame
72hrs
Title
left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion
Time Frame
2-8weeks and 6-12months
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
2.7years (median follow-up)
Title
cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
Time Frame
2.7years (median follow-up)
Title
reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
Time Frame
24hrs
Title
the association of SNPs of ANP-related genes with response to ANP treatment
Time Frame
2.7years (median follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masafumi Kitakaze, MD, PhD
Organizational Affiliation
National Cerebral and Cardiovascular Center, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
National Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
544-0024
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
14745142
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.
Results Reference
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Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by ANP
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