UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012369
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

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Basic information

Public title

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

Acronym

Ultrasound therapy for ischemic heart disease

Scientific Title

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

Scientific Title:Acronym

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

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

022-717-7152

Email

shimo@cardio.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiko Shindo

Organization

Tohoku University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1 Seiryomachi, Aoba-ku, Sendai 980-9574

TEL

022-717-7153

Homepage URL


Email

t-shindo@cardio.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



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)



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)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 21 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

Open public recruiting

Date of protocol fixation

2013 Year 11 Month 08 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name