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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014637
Receipt No. R000017029
Scientific Title Comprehensive evaluation of coronary arterial dysfunction using peripheral vascular dysfunction and 3D PET/CT
Date of disclosure of the study information 2014/08/01
Last modified on 2015/08/24

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Basic information
Public title Comprehensive evaluation of coronary arterial dysfunction using peripheral vascular dysfunction and 3D PET/CT
Acronym Peripheral arterial Area and Vascular Elasticity measurements Study (PAVE Study)
Scientific Title Comprehensive evaluation of coronary arterial dysfunction using peripheral vascular dysfunction and 3D PET/CT
Scientific Title:Acronym Peripheral arterial Area and Vascular Elasticity measurements Study (PAVE Study)
Region
Japan

Condition
Condition Coronary artery disease, Chronic kidney, disease, Hypertension, Diabetes mellitus
Classification by specialty
Cardiology Nephrology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1 First aim of this study is to develop comprehensive methods of detecting vascular function. For this purpose, we would look into the association between brachial arterial artery endothelial function measured by FMD (flow mediated dilattion) and coronary artery dysfunction detected using 15O-water 3D PET/CT.

2 Second aim of this study is to evaluate the associations among myocardial blood flow and brachial artery function calculated by ultrasound and an automated oscillometric method to measure a brachial artery function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The association between brachial artery diameter ,FMD measured by ultrasound, and MBF (myocardial Blood Flow) at rest, ATP(adenosinetriphosphate) stress and, CPT (Cold Pressor Test) stress. CFR(coronary flow reserve), CPT response evaluated by 3D PET/CT will also be compared to FMD and NTG response.
Key secondary outcomes The association between vascular elasticity,brachial arterial diameter measured by automated oscillometric method and brachial diameters and artery function measured by brachial artery ultrasound.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Patients with coronary artery disease, patients having atherosclerotic risks,
Normal individual
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 CAD (coronary artery disease) or suspected CAD.

2.Patient have risk of atherosclerosis , such as hypertension, DM (Diabetes Mellitus), kidney disease and smoker.
Key exclusion criteria 1.Advanced AV block
2.Bronchial asthma
3.Pregnant women
4.Subjects who will not be able to obtain written informed concent.
5.Others who physicians will consider the contraindication for the participation.
Target sample size 65

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C.
Organization Hokkaido University Graduate School of Medicine
Division name Department of molecular imaging
Zip code
Address Kita-15, Nishi-7, Kita-Ku, Sapporo
TEL 011-706-5152
Email kyoshi@med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yoshinaga, M.D., Ph.D, F.A.C.C.
Organization Hokkaido University Graduate School of Medicine
Division name Department of molecular imaging
Zip code
Address Kita-15, Nishi-7, Kita-Ku, Sapporo
TEL 011-706-5152
Homepage URL
Email kyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine,
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science Research
A&D Co.,LtD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2015 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017029

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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