UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029777 |
|---|---|
| Receipt number | R000033986 |
| Scientific Title | Observational study for coronary vasoreactivity to exercise in patients with vasospastic angina |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/05/03 16:48:47 |
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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
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
hao@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
