UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019245 |
|---|---|
| Receipt number | R000022242 |
| Scientific Title | Evaluation of coronary macro- and micro-vascular function after drug-eluting stent |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2015/10/05 22:50:19 |
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Basic information
Public title
Evaluation of coronary macro- and micro-vascular function after drug-eluting stent
Acronym
Coronary vascular function after DES
Scientific Title
Evaluation of coronary macro- and micro-vascular function after drug-eluting stent
Scientific Title:Acronym
Coronary vascular function after DES
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of coronary vascular function after DES implantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
extent of vascular dysfunction
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients treated with second generation DES
Key exclusion criteria
STEMI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Hokimoto |
Organization
Kumamoto Unoversity
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5175
shokimot@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Hokimoto |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5175
Homepage URL
shokimot@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
donation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
About half of the patients undergoing DES implantation showed coronary spasm.
Management information
Registered date
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2015 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022242
