UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016675
Receipt number R000019261
Scientific Title Morphological and Functional Change of Coronary Perivascular Adipose Tissue in Vasospastic Angina
Date of disclosure of the study information 2015/03/09
Last modified on 2018/03/04 12:00:19

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Basic information

Public title

Morphological and Functional Change of Coronary Perivascular Adipose Tissue in Vasospastic Angina

Acronym

ADIPO-VSA Trial

Scientific Title

Morphological and Functional Change of Coronary Perivascular Adipose Tissue in Vasospastic Angina

Scientific Title:Acronym

ADIPO-VSA Trial

Region

Japan


Condition

Condition

Vasospastic angina

Classification by specialty

Medicine in general Cardiology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the relationship between vasospastic angina and morphological and functional change of coronary perivascular adipose tissue.

Basic objectives2

Others

Basic objectives -Others

Morphological change of coronary perivascular adipose tissue is assessed by volume measured by cardiac CT, functional change is assessed by FDG-uptake measured by 18F-FDG PET.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

(1)Coronary perivascular adipose tissue volume measured by cardiac CT.

Key secondary outcomes

(2)FDG-uptake of coronary perivascular adipose tissue measured by 18F-FDG PET.
(3)FDG-uptake of vascular wall in which vasospasm occurs measured by 18F-FDG PET.
(4)Vasa vasorum measured by OFDI
(5)General blood examination deta, adiponectin, Rho-kinase activity
(6)Metabolite measured by metabolome analysis
(7)Exercise tolerance measured by cardiopulmonary exercise test
(8)FDG-uptake of coronary perivascular adipose tissue measured by 18F-FDG PET at the time of follow-up.


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

Patients who are suspected of vasospastic angina.

Key exclusion criteria

(1) Acute coronary syndrome
(2) EF is under 40%.
(3) Severe renal failure.
(4) Severe contrast media allergy
(5) history of cardiac surgery
(6) Severe asthma
(7) Diabetes which needs insulin therapy

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Shimokawa

Organization

Tohoku University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan

TEL

+81-22-717-7153

Email

shimo@cardio.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuharu Matsumoto

Organization

Tohoku University Hospital

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan

TEL

+81-22-717-7153

Homepage URL


Email

matsumoto@cardio.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Mochida Memorial Foundation for Medical and Pharmaceutical Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Banyu Life Science Foundation International


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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 09 Day

Last follow-up date

2017 Year 07 Month 31 Day

Date of closure to data entry

2017 Year 07 Month 31 Day

Date trial data considered complete

2017 Year 07 Month 31 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information

Patient's information is blinded to a person analyzing data of CT and PET.


Management information

Registered date

2015 Year 03 Month 02 Day

Last modified on

2018 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name