UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014637 |
|---|---|
| Receipt number | 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 11:55:31 |
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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
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
kyoshi@med.hokudai.ac.jp
Public contact
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
kyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017029
