UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039764 |
|---|---|
| Receipt number | R000045345 |
| Scientific Title | Relationship between FFR and iFR in patients with HD |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/11 11:26:09 |
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Basic information
Public title
Relationship between FFR and iFR in patients with HD
Acronym
Relationship between FFR and iFR in patients with HD
Scientific Title
Relationship between FFR and iFR in patients with HD
Scientific Title:Acronym
Relationship between FFR and iFR in patients with HD
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the relationship between fractional flow reserve (FFR) and instantaneous wave-free ration (iFR) in hemodialysis patients with cardiac echo and cardiac computed tomography findings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between iFR and FFR in hemodialysis patients
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
Hemodialysis patients with coronary artery disease performed diagnostic coronary angiogram and physiological assessment with iFR and FFR
Key exclusion criteria
not applicable
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tairo |
| Middle name | |
| Last name | Kurita |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174 Edobashi, Tsu 514-8507, Japan
TEL
059-231-5021
k_siho_yuu@hotmail.com
Public contact
Name of contact person
| 1st name | akihiro |
| Middle name | |
| Last name | takasaki |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174 Edobashi, Tsu 514-8507, Japan
TEL
059-231-5021
Homepage URL
takasakiman@gmail.com
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology and Nephrology, Mie 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
Mie University Graduate School of Medicine Ethics comittee
Address
2-174 Edobashi, Tsu 514-8507, Japan
Tel
059-232-1111
s-kenkyu3@mo.medic.mie-u.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
| 2020 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045345
