UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019062 |
|---|---|
| Receipt number | R000021449 |
| Scientific Title | A long term assessment for factors having an impact on the patency of saphenous vein graft following coronary artery bypass grafting |
| Date of disclosure of the study information | 2015/09/18 |
| Last modified on | 2015/09/27 20:46:15 |
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Basic information
Public title
A long term assessment for factors having an impact on the patency of saphenous vein graft following coronary artery bypass grafting
Acronym
A long term assessment for factors having an impact on the patency of saphenous vein graft following coronary artery bypass grafting
Scientific Title
A long term assessment for factors having an impact on the patency of saphenous vein graft following coronary artery bypass grafting
Scientific Title:Acronym
A long term assessment for factors having an impact on the patency of saphenous vein graft following coronary artery bypass grafting
Region
| Japan |
Condition
Condition
Ischemic cardiac disease(effort angina pectoris,asymptomatic myocardial ischemia,acute coronary syndrome
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One of two aims is to clarify risk factors associated with the occlusion of vein graft by evaluating patient characteristics, pathological finding and blood flow velocity of vein graft, intravascular image by optical coherence tomography (OCT), inflammatory and vasoactive biomarker in the patient underwent coronary bypass grafting (CABG) using the vein graft,
The other is to detect graft failures one year after CABG by graftgraphy even if the subject with silent myocardial ischemia. And, adequate medical intervention can be provided by revascularization or optimal medical therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patency of saphenous vein graft one year after CABG
Key secondary outcomes
1) Lumen area, intimal thickening and incidence of thrombus evaluated by OCT
2) Coronary flow velocity of saphenous vein graft
3) Value of inflammatory and vasoactive biomarker
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 meeting all of the following conditions will be included:
1) underwent coronary bypass grafting using the vein graft
2) between 20 and 85 years old
3) written consent for participation in the study
Key exclusion criteria
Patients meeting one of the following conditions will be excluded:
1) severe liver dysfunction
2) renal dysfunction (Cre>= 2.0mg/dL)
3) severe heart failure (NYHA/New York Heart Association stage III or severer)
4) malignancies or other diseases with poor prognosis
5) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
6) judged as ineligible by clinical investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5111
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5111
Homepage URL
y_nagano1981@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 09 | Month | 18 | 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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
This is cohort study for evaluating risk factors of graft occlusion at the mid term follow-up after CABG.
Management information
Registered date
| 2015 | Year | 09 | Month | 18 | Day |
Last modified on
| 2015 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021449
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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