UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Morphological and Functional Change of Coronary Perivascular Adipose Tissue in Vasospastic Angina
Title of the study (Brief title)	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	Hiroaki Shimokawa
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
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	Yasuharu Matsumoto
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
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
Institute	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019261