UMIN-CTR Clinical Trial

Basic information
Public title	Observational study for coronary vasoreactivity to exercise in patients with vasospastic angina
Acronym	Observational study for coronary vasoreactivity to exercise in patients with vasospastic angina
Scientific Title	Observational study for coronary vasoreactivity to exercise in patients with vasospastic angina
Scientific Title:Acronym	Observational study for coronary vasoreactivity to exercise in patients with vasospastic angina
Region	Japan

Condition
Condition	Vasospastic angina
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the coronary vasoreaction to exexercise in patient with vasospastic angina
Basic objectives2	Others
Basic objectives -Others	observasional study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the coronary vasoreaction to exexercise in patient with vasospastic angina
Key secondary outcomes

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 suspected to have angina and scheduled to undergo coronary angiogram
Key exclusion criteria	Patients with severe coronary onganic stenosis Patients with acute coronary syndrome Patients with severe renal falure Patients with severe athema Patinets with allergy to contrast medium or acetylcholine Patients who cannot exercise with elgometer
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takahashi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7152
Email	jtakahashi@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Kiyotaka Middle name Last name Hao
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7153
Homepage URL
Email	hao@cardio.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku university graduate school of medicine
Address	1-1 Seiryo-machi, Aoba-ku
Tel	022-728-4105
Email	rinri-2@proj.med.tohoku.ac.jp

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	2017 Year 11 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	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 15 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 10 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To examine the prognostic impact of vasoreaction to exercise in patients with vasspastic angina

Management information
Registered date	2017 Year 10 Month 31 Day
Last modified on	2020 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033986