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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 2012/04/01

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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
Middle name
Last name Kenta Ito, Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai
TEL 022-717-7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Ito
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
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 Graduate School of Medicine
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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
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
2012 Year 04 Month 01 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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