UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016675
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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

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
URL(English) https://upload.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


Contact us.