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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023996
Receipt No. R000027624
Scientific Title Effect of exercise training on exercise tolerance capacity,coronary microcirculation and adventitia in patients with vasospastic angina.
Date of disclosure of the study information 2016/09/09
Last modified on 2019/03/13

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Basic information
Public title Effect of exercise training on exercise tolerance capacity,coronary microcirculation and adventitia in patients with vasospastic angina.
Acronym Exercise-VSA Study
Scientific Title Effect of exercise training on exercise tolerance capacity,coronary microcirculation and adventitia in patients with vasospastic angina.
Scientific Title:Acronym Exercise-VSA Study
Region
Japan

Condition
Condition Vasospastic angina
Classification by specialty
Medicine in general Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of exercise on coronary vasomotion and exercise tolerance capacity in patient with vasospastic angina.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes (1)Change of exercise tolerance capacity assessed by cardiopulmonary testing.
Key secondary outcomes (2)Coronary perivascular adipose tissue volume and myocardial circulation.
(3)General blood examination data, Rho-kinase activity.
(4)Change of QOL score assessed by questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Patients with vasospastic angina are randomly assigned either to a training group or to an control group.
Patients assigned to the training program are provided with a bicycle ergometer and instructed to exercise 30 minutes per day at target heart rate measured by cardiopulmonary exercise testing at home for 3 months, 3-5days per week.Target heart rate is their heart rate at anaerobic threshold.In addition, they participate in the weekly training program
Interventions/Control_2 Patients assigned to the control group don't participated in training program.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with 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
(8) Patients with coronary artery stenosis>75%
(9) Patients suspected exercise induced vasoconstriction
(10) Patients with chronic obstructive pulmonary disease
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Shimokawa
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code 9808574
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 Yasuharu
Middle name
Last name Matsumoto
Organization Tohoku University Hospital
Division name Department of Cardiovascular Medicine
Zip code 9808574
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 Ministry of education
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 Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan,
Tel +8122-728-4105
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
2016 Year 09 Month 09 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
2016 Year 08 Month 17 Day
Date of IRB
2016 Year 08 Month 01 Day
Anticipated trial start date
2016 Year 09 Month 09 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 09 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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