UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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