UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014562 |
|---|---|
| Receipt number | 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 22:57:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cswt@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
