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

Email

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


Email

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


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

Value
https://center6.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