UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018160
Receipt number R000020670
Scientific Title Effects of Revascularization on Coronary Flow Reserve in Patients with Coronary Artery Disease: O-15 Water Positron Emission Tomography Study
Date of disclosure of the study information 2015/07/02
Last modified on 2020/01/04 12:54:39

* 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

Effects of Revascularization on Coronary Flow Reserve in Patients with Coronary Artery Disease: O-15 Water Positron Emission Tomography Study

Acronym

Effects of Revascularization on CFR in Patients with CAD: O-15 Water PET Study

Scientific Title

Effects of Revascularization on Coronary Flow Reserve in Patients with Coronary Artery Disease: O-15 Water Positron Emission Tomography Study

Scientific Title:Acronym

Effects of Revascularization on CFR in Patients with CAD: O-15 Water PET Study

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology Radiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our objective is to evaluate the effects of optimal medical therapy and/or revascularization in patients with coronary artery disease by O-15 water positron emission tomography/computed tomography.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Rest myocardial blood flow (MBF), stress MBF, and coronary flow reserve by quantitative O-15 water positron emission tomography/computed tomography between pre- and post-treatment in patients with coronary artery disease.

Key secondary outcomes

The prespecified secondary outcomes of the study are described below.
1. To assess predictors of improvement in CFR
2. To assess predictors of CFR at baseline


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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. Patients with suspected or known stable coronary artery disease (CAD) who regularly visits 4 Japanese study sites are eligible.
2. Patients 20 years of age and older are eligible.
3. All patients receive from physicians the information necessary to give informed consent in writing to receive O-15 water positron emission tomography/computed tomography.
Four Japanese study sites are as follows: Hokkaido University Hospital, Sapporo City General Hospital, ShinSapporo Hospital of Cardiology, Keiwakai Ebetsu Hospital

Key exclusion criteria

Exclusion criteria in patients' eligibility are described below.
1. Patients with a history of advanced atrioventricular block
2. Patients with bronchial asthma
3. Patients with suspected or known pregnancy
4. Patients who cannot give written consent
5. Patients who contact persons judge as ineligible for this study

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Masanao
Middle name
Last name Naya

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

060-8643

Address

Kita-15, Nishi-7, Kita-ku, Sapporo 060-8638, Japan

TEL

+81117066973

Email

naya@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Masanao
Middle name
Last name Naya

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

060-8638

Address

Sapporo

TEL

011-706-6973

Homepage URL


Email

naya@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

Takeda Scientific Foundation


IRB Contact (For public release)

Organization

Hokkaido University Graduate School of Medicine

Address

Sapporo

Tel

011-706-7636

Email

crjimu@huhp.hokudai.ac.jp


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

北海道大学病院(北海道),市立札幌病院(北海道),新札幌循環器病院(北海道),渓和会江別病院(北海道)


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 02 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

Cardiovascular Research 2019,115,119-129

Number of participants that the trial has enrolled

82

Results

Please see a paper above

Results date posted

2019 Year 10 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 01 Month 01 Day

Baseline Characteristics

Please see a paper above

Participant flow

Please see a paper above

Adverse events

None

Outcome measures

Please see a paper above

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB

2015 Year 06 Month 30 Day

Anticipated trial start date

2015 Year 06 Month 30 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

We will prospectively perform this non-randomized observational study. We will evaluate relationships between improvement in coronary flow reserve (CFR), CFR at baseline, and the following information.
1) Physical measurements
2) Laboratory data results
3) Physiological function testing
4) Questionnaire data and medical records about coronary risk factors
5) Coronary artery calcium score in computed tomography (CT)
6) Imaging tests, including coronary angiography, myocardial perfusion image, cardiac magnetic resonance imaging, coronary CT angiography, and dobutamine stress echocardiography
7) Revascularization, including percutaneous coronary intervention and coronary-artery bypass grafting
8) Antianginal medications


Management information

Registered date

2015 Year 07 Month 02 Day

Last modified on

2020 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name