UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000389 |
|---|---|
| Receipt number | R000000481 |
| Scientific Title | A randomazied controlled study to evaluate efficacy of low-energy extracorporeal cardiac shock wave therapy in patients with severe coronary artery disease |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2020/03/08 11:01:46 |
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Basic information
Public title
A randomazied controlled study to evaluate efficacy of low-energy extracorporeal cardiac shock wave therapy in patients with severe coronary artery disease
Acronym
Effect of low-energy extracorporeal cardiac shock wave therapy in patients with severe coronary artery disease
Scientific Title
A randomazied controlled study to evaluate efficacy of low-energy extracorporeal cardiac shock wave therapy in patients with severe coronary artery disease
Scientific Title:Acronym
Effect of low-energy extracorporeal cardiac shock wave therapy in patients with severe coronary artery disease
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether low-energy extracorporeal cardiac shock wave therapy can improve regional myocardial ischemia in patients with severe coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Regional myocardial ischemia.
Evaluated at 3 month after the therapy.
Key secondary outcomes
Symptoms (CCS class scores, Frequency in use of nitroglycerin per week), Exercise tolerance.
Evaluated at 3 month after the therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Extracorporeal cardiac shock wave therapy (3 times a week/series, 200 shots/spot at 0.09 mJ/mm2 for 20-120 spots each time)
Interventions/Control_2
Placebo treatment (3 times a week/series)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severe coronary artery disease suffered from stable effort angina with evidence of myocardial ischemia even after adequate medications and with no indication of percutaneous coronary intervention or coronary artery bypass grafting because of diffuse distal coronary artery narrowing.
Key exclusion criteria
1. Q-wave or non-Q-wave myocardial infarction within 3 months.
2. Cardiac transplantation.
3. Left ventricular thrombus.
4. Poorly controlled diabetic retinopathy.
5. Malignant tumor including operation for the tumor within 5 years.
6. PCI and/or CABG within 3 months.
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
980-8575
Address
1-1 Seiryomachi, Aoba-ku, Sendai
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
980-8575
Address
1-1 Seiryomachi, Aoba-ku, Sendai
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
| 2006 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/74/3/74_CJ-09-1028/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/74/3/74_CJ-09-1028/_article
Number of participants that the trial has enrolled
8
Results
SW therapy, but not placebo, significantly improved chest pain symptoms and cardiac function without any complications or adverse effects.
Results date posted
| 2020 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 8 consecutive patients with severe angina pectoris who already had undergone CABG or PCI, but who no longer had further indications for these therapies even though they still suffered from stable effort angina under intensive medication (M/F, 5/3; age, 70+/-3 years).
Participant flow
Patients were enrolled in 1 institute in Japan.
Adverse events
None.
Outcome measures
Regional myocardial ischemia.
Symptoms (CCS class scores, Frequency in use of nitroglycerin per week), Exercise tolerance.
Evaluated at 3 month after the therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000481
