UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000003003 |
| Receipt No. | 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 (Ver. 18) |
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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 |
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| Condition | ||
| Condition | Angina pectoris | |
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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. |
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| 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. |
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| Target sample size | 50 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 | 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| 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. |
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| Participant flow | Patients were enrolled in 4 institutes in Japan. |
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| Adverse events | None. |
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| 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. |
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| Recruitment status | Completed | ||||||
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| Date analysis concluded | |||||||
| Other | |
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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=R000003631 |
