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
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
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
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
