UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with ischemic heart disease
Title of the study (Brief title)	Ultrasound 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 improve quality of life (QOL) in patients with refractory angina pectoris by developing a new therapeutic device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency in use of nitrates per week.
Key secondary outcomes	Symptom (CCS class scores, Frequency of chest pain per week). Exercise tolerance (Treadmill test, 6-minute walk test). Myocardial perfusion (Stress myocardial perfusion scintigraphy). Cardiac function (only in pts. with LVEF =< 40%).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Ultrasonic irradiation (Ultrasonic irradiation to the heart for 20 minutes x 3 times).
Interventions/Control_2	Placebo therapy.
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) Informed consent in writing. 2) Men and women 20 years of age or older. 3) Patients who are able to be admitted to a hospital for at least 6 days. 4) Patients with refractory angina pectoris who have no indication of revascularization (PCI or CABG) or in whom the risk of revascularization therapy does not meet the expected improvement. 5) Patients who have chest pain even under standard medical therapy and use at least one use of nitrates per week. 6) Evidence of myocardial ischemia with myocardial stress-scintigraphy. 7) Able to fill out a trial notebook for recording the frequency of nitrate use and chest pain.
Key exclusion criteria	1) Patients whose target area cannot be observed with echocardiography. 2) Intracardiac thrombus. 6) Less than 28 days after the last revascularization (PCI or CABG). 4) Q-wave myocardial infarction within 28 days. 5) Non-Q-wave myocardial infarction within 42 days. 6) Cardiogenic shock or worsening heart failure (to require continuous infusion of cardiovascular agents such as inotropic agents or vasodilator ). 7) Patients whose clinical condition changed after the last coronary angiography. 8) Uncontrolled diabetic retinopathy. 9) Patients who have malignant tumor or who have undergone surgery because of malignancy within the past five years.
Target sample size	80

Research contact person
Name of lead principal investigator	Hiroaki Shimokawa
Organization	Tohoku University
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
TEL	022-717-7152
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	Tomohiko Shindo
Organization	Tohoku University
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
TEL	022-717-7153
Homepage URL
Email	t-shindo@cardio.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Special Funds for Education and Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology, Tokyo, Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 08 Day
Anticipated trial start date	2013 Year 12 Month 15 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 06 Month 30 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 21 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014316