UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000014562
Receipt No. R000016756
Scientific Title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Date of disclosure of the study information 2014/07/15
Last modified on 2020/03/07 (Ver. 8)

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Basic information
Public title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Acronym Shock wave therapy for AMI
Scientific Title Low-energy extracorporeal cardiac shock wave therapy in patients with acute myocardial infarction
Scientific Title:Acronym Shock wave therapy for AMI
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To suppress left ventricular (LV) remodeling after acute myocardial infarction (AMI)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LV volume and LV ejection fraction at 6 months and 12 months after AMI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Low-energy extracorporeal cardiac shock wave therapy (3 times in the first week. 30 or less spots around infarcted area, 200 shots/spot each time)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) 20-79 year-old men, 20-74-year-old women.
2) Reperfusion therapy is succeeded with no distal emboli.
3) Therapy can be started within 72 hours after the onset of AMI.
4) The peak CK in serum is 4000 U/L or less.
Key exclusion criteria 1) Patients with cardiogenic shock or congestive heart failure (who require continuous infusion of cardiovascular agents such as inotropic agents or vasodilators).
2) Patients with severe arrhythmia requiring a cardioversion procedure after PCI.
3) Broad anterior AMI.
4) Patients whose target area cannot be observed with echocardiography.
5) Post-breast augmentation surgery with silicon pad.
6) Intracardiac thrombus.
7) Patients who have malignancy or who have undergone surgery because of malignancy within the past five years.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-5874
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7153
Email cswt@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kenta
Middle name
Last name Ito
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-8574
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7153
Homepage URL http://www.cardio.med.tohoku.ac.jp/shockwave/index.html
Email cswt@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
Tel 022-717-7122
Email cswt@cardio.med.tohoku.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 15 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/29068804
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29068804
Number of participants that the trial has enrolled 17
Results 
At 6 and 12 months after AMI, LV function as assessed by MRI showed no signs of deleterious LV remodeling. When we compared the SW-treated group with the historical AMI controls at 6 months after AMI, LV ejection fraction was significantly higher in the SW-treated group (N=7) than in the historical control group (N=25) by echocardiography. LV end-diastolic dimension also tended to be smaller in the SW than in the control group.
Results date posted
2020 Year 03 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Seventeen patients with AMI who successfully underwent primary PCI (peak-creatine kinase<4000U/l) were treated with the SW therapy.
Participant flow 
Registered in one institute.
Adverse events 
There were no procedure-related complications or adverse effects.
Outcome measures 
LV function as assessed by MRI.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 11 Month 20 Day
Date of IRB
2007 Year 02 Month 05 Day
Anticipated trial start date
2007 Year 02 Month 18 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2020 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016756