Unique ID issued by UMIN | UMIN000012369 |
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Receipt number | R000014316 |
Scientific Title | Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with ischemic heart disease |
Date of disclosure of the study information | 2013/11/21 |
Last modified on | 2017/02/10 08:26:04 |
Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with ischemic heart disease
Ultrasound therapy for ischemic heart disease
Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with ischemic heart disease
Ultrasound therapy for ischemic heart disease
Japan |
Angina pectoris
Cardiology |
Others
NO
To improve quality of life (QOL) in patients with refractory angina pectoris by developing a new therapeutic device.
Safety,Efficacy
Confirmatory
Frequency in use of nitrates per week.
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%).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Central registration
2
Treatment
Device,equipment |
Ultrasonic irradiation (Ultrasonic irradiation to the heart for 20 minutes x 3 times).
Placebo therapy.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
80
1st name | |
Middle name | |
Last name | Hiroaki Shimokawa |
Tohoku University
Department of Cardiovascular Medicine
1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
022-717-7152
shimo@cardio.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Tomohiko Shindo |
Tohoku University
Department of Cardiovascular Medicine
1-1 Seiryomachi, Aoba-ku, Sendai 980-9574
022-717-7153
t-shindo@cardio.med.tohoku.ac.jp
Tohoku University
Special Funds for Education and Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology, Tokyo, Japan.
Japanese Governmental office
Japan
NO
東北大学病院(宮城県)
2013 | Year | 11 | Month | 21 | Day |
Unpublished
Open public recruiting
2013 | Year | 11 | Month | 08 | Day |
2013 | Year | 12 | Month | 15 | Day |
2019 | Year | 10 | Month | 31 | Day |
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 09 | Month | 30 | Day |
2013 | Year | 11 | Month | 21 | Day |
2017 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014316
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