UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003003 |
|---|---|
| Receipt number | R000003631 |
| Scientific Title | Low-energy extracorporeal cardiac shock wave therapy in patients with severe ischemic heart disease |
| Date of disclosure of the study information | 2010/01/12 |
| Last modified on | 2020/03/07 22:13:40 |
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Basic information
Public title
Low-energy extracorporeal cardiac shock wave therapy in patients with severe ischemic heart disease
Acronym
Shock wave therapy for ischemic heart disease
Scientific Title
Low-energy extracorporeal cardiac shock wave therapy in patients with severe ischemic heart disease
Scientific Title:Acronym
Shock wave therapy for ischemic heart disease
Region
| Japan |
Condition
Condition
Angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of low-energy extracorporeal cardiac shock wave therapy in patients with severe angina pectoris
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency in use of nitroglycerin per week.
Evaluated at 3 month after the therapy.
Key secondary outcomes
CCS class scores, Exercise tolerance, Myocardial perfusion.
Evaluated at 3 month after the therapy.
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
Extracorporeal cardiac shock wave therapy (3 times in the first week, 200 shots/spot at about 0.1 mJ/mm2 for 40-70 spots 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women 20 years of age or older.
2) Patients who have chest pain even under standard medication.
3) Patients with no indication of revascularization (PCI or CABG), or patients in whom eonugh improvement is not expected compared to the risk of revascularization.
4) Canadian Cardiovascular Society (CCS) classification, Class II-IV patients.
5) Evidence of myocardial ischemia with myocardial stress-scintigraphy or stress MRI.
Key exclusion criteria
1) Patients whose target area cannot be observed with echocardiography.
2) Post-breast augmentation surgery with silicon pad.
3) Patients with prosthetic valve (mechanical valve) in the heart.
4) Q-wave myocardial infarction within 3 months.
5) Non-Q-wave myocardial infarction within 6 weeks.
6) Less than 1 month after the last revascularization (PCI or CABG).
7) Patients with cardiogenic shock or worsening heart failure (who require continuous infusion of cardiovascular agents such as inotropic agents or vasodilators).
8) Intracardiac thrombus.
9) Patients whose clinical status changed after the last coronary angiography.
10) Unstable diabetic retinopathy.
11) Patients who have malignancy or who have undergone surgery because of malignancy within the past five years.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shimokawa |
Organization
Tohoku University
Division name
Department of Cardiovascular Medicine
Zip code
980-8575
Address
1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
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
Division name
Department of Cardiovascular Medicine
Zip code
980-8575
Address
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
東北大学病院（宮城県）、石川県立中央病院（石川県）、藤田保健衛生大学病院（愛知県）、千葉西総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs00380-018-1215-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00380-018-1215-4
Number of participants that the trial has enrolled
50
Results
CSWT markedly improved weekly nitroglycerin use and the symptoms. CSWT also significantly improved 6-min walking distance. Percent myocardium ischemia assessed by drug-induced stress MPI tended to be improved only in the treated segments.
Results date posted
| 2020 | Year | 03 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty patients with refractory AP [mean age 70.9+/-12.6(SD) years, M/F 38/12] without the indications of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were enrolled in 4 institutes in Japan.
Participant flow
Patients were enrolled in 4 institutes in Japan.
Adverse events
None.
Outcome measures
Weekly nitroglycerin use.
Symptoms.
Canadian Cardiovascular Society functional class score.
6-min walking distance.
LV ejection fraction.
LV stroke volume.
Percent myocardium ischemia assessed by drug-induced stress MPI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | 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
| 2010 | Year | 01 | Month | 09 | 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=R000003631
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