UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029867 |
|---|---|
| Receipt number | R000034040 |
| Scientific Title | Diagnostic Performance of Fractional Flow Reserve, Coronary Flow Reserve and Index of the Micro-circulatory Resistance |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/05/18 17:19:09 |
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Basic information
Public title
Diagnostic Performance of Fractional Flow Reserve, Coronary Flow Reserve and Index of the Micro-circulatory Resistance
Acronym
Diagnostic Performance of Fractional Flow Reserve, Coronary Flow Reserve and Index of the Micro-circulatory Resistance
Scientific Title
Diagnostic Performance of Fractional Flow Reserve, Coronary Flow Reserve and Index of the Micro-circulatory Resistance
Scientific Title:Acronym
Diagnostic Performance of Fractional Flow Reserve, Coronary Flow Reserve and Index of the Micro-circulatory Resistance
Region
| Japan |
Condition
Condition
Patients with suspected coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prognosis of cases in which FFR, CFR and IMR were measured for moderate coronary artery stenosis
Basic objectives2
Others
Basic objectives -Others
To analyze dissociated factors of FFR and CFR
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis of cases in which FFR, CFR, IMR were measured
Key secondary outcomes
factorial analysis for divergent cases of FFR and CFR
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)Patients suspected with coronary artery disease
(2)Patients with visually estimated moderate coronary artery stenosis
Key exclusion criteria
(1)contraindication to adenosine
(2)clinically active bronchial asthma
(3)chronic total occlusion lesion
(4)Lesions inappropriate for FFR
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467461717
futoshi-yamanaka@nifty.com
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467461717
Homepage URL
futoshi-yamanaka@nifty.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
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
Tokushukai Group Institutional Review Board
Address
Chiyodaku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2018 | Year | 05 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | 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
no special instruction
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034040
