UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000018160 |
| Receipt No. | 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 (Ver. 14) |
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| 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 | |
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| Condition | ||||
| Condition | coronary artery disease | |||
| Classification by specialty |
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| 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 | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 90 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | KAKENHI
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| 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) |
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| Date of disclosure of the study information |
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| 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 |
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| Results date posted |
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| Baseline Characteristics | Please see a paper above |
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| Participant flow | Please see a paper above |
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| Adverse events | None |
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| Outcome measures | Please see a paper above |
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| Progress | |||||||
| Recruitment status | Main results already published | ||||||
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| 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 |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020670 |
