UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

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 2018/01/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
TEL 022-717-7153
Email cswt@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Ito
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 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
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 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
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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
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
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.