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Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012369
Enrollment
80
Registered
2013-11-21
Start date
2013-12-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina pectoris

Interventions

Ultrasonic irradiation (Ultrasonic irradiation to the heart for 20 minutes x 3 times). Placebo therapy.

Sponsors

Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Frequency in use of nitrates per week.

Secondary

MeasureTime frame
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%).

Countries

Japan

Contacts

Public ContactTomohiko Shindo

Tohoku University Department of Cardiovascular Medicine

t-shindo@cardio.med.tohoku.ac.jp022-717-7153

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026