UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012104 |
|---|---|
| Receipt number | R000014143 |
| Scientific Title | Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect. |
| Date of disclosure of the study information | 2013/10/22 |
| Last modified on | 2016/08/25 16:36:24 |
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Basic information
Public title
Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Acronym
Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Scientific Title
Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Scientific Title:Acronym
Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether iFR/FFR guided treatment strategy makes the postulated treatment strategy by CAG guide change and to analyze the cost-effectiveness of its dual diagnosis.
To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Primary outcome of medical economy
The cost-effectiveness of iFR/FFR hybrid strategy
2. Primary outcome of physiological assessment
Alteration in treatment protocol
Change in SYNTAX score
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
1. Age>=20 years old.
2. Patient who can understand informed consent of the clinical study and signed the consent.
3. Patient who is adaptable to CAG and/or coronary revascularization
4. Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.
Key exclusion criteria
1. Patient with known contraindications to ATP and/or papaverine hydrochloride
2. Target vessel diameter<=2.0mm
3. Lesion with CTO (registration allowed if other branch has stenosis more than 50% in visual judgment)
4. Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
5. AMI patient
6. Patient who is disqualified for FFR and coronary revascularization by the investigator.
7. Lesion is disqualified for PCI by the investigator.
8. Patient who has critical valvular disease of heart. (moderate or severe AS/AR/MS/MR)
9. Patient with a prior CABG on target vessel.
10. Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl)
11. Patient on hemodialysis.
12. Body weight>=200kg
13. Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg)
14. Patient who expects to live less than 2 years at the registration
15. Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy.
16. Patient who is poor compliance with drug treatment.
17. Patient who is allergic to contrast agent.
18. LVEF>=30%
19. Patient who has the history of PCI with DES in recent 3 months before registration.
20. Patient who has the history of PCI with BMS or POBA in recent 1 year before registration.
21. Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI.
22. Patients with inadequacy to join this clinical study.
23. Patient who has been enrolled any other clinical study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nakamura |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
Address
2-17-6, Ohashi Meguro-ku, Tokyo 153-8515
TEL
+81-3-3468-1251
masato@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
J-DEFINE support center
Division name
Soiken Inc.
Zip code
Address
NFB Ogawa-cho Bldg 4F, 1-3-1, Kanda Ogawa-cho, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1376
Homepage URL
info@j-define.org
Sponsor or person
Institute
NPO Associations for Establishment of Evidence in Interventions
Institute
Department
Personal name
Funding Source
Organization
NPO Associations for Establishment of Evidence in Interventions
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
| 2013 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nonrandomized, open-label, prospective, and multi-center observational study
Management information
Registered date
| 2013 | Year | 10 | Month | 22 | Day |
Last modified on
| 2016 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014143
| Research Plan | |
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| 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 |
