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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000389 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Ischemic heart disease | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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. |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000481 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |