UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023996 |
|---|---|
| Receipt number | 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 12:35:30 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027624
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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