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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029790
Receipt No. R000034015
Scientific Title The Effectiveness of Fractional Flow Reserve, Coronary Flow Reserve and the Index of Micro-circulatory resistance in Patients with Hemodialysis.
Date of disclosure of the study information 2020/04/01
Last modified on 2021/05/18

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Basic information
Public title The Effectiveness of Fractional Flow Reserve, Coronary Flow Reserve and the Index of Micro-circulatory resistance in Patients with Hemodialysis.
Acronym The Effectiveness of Fractional Flow Reserve in Hemodialysis Patients.
Scientific Title The Effectiveness of Fractional Flow Reserve, Coronary Flow Reserve and the Index of Micro-circulatory resistance in Patients with Hemodialysis.
Scientific Title:Acronym The Effectiveness of Fractional Flow Reserve in Hemodialysis Patients.
Region
Japan

Condition
Condition Hemodialysis patients with intermediate coronary artery stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the diagnostic performance of FFR and CFR in patients with hemodialysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FFR and CFR assessment compared with radioisotope perfusion images
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 visually estimated moderate coronary artery stenosis

Key exclusion criteria 1. contra-indication to adenosine infusion
2. inadequate lesion to do FFR, CFR
3. unstable hemodynamic state(Heat rate<4
0, systolic Blood pressure less than 40mmHg)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Saito
Organization Shonan Kamakura General Hospital
Division name Department of Cardiology
Zip code 2478533
Address Okamoto1370-1, Kamakura, Kanagawa, Japan
TEL 0467461717
Email 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 Okamoto1370-1, Kamakura, Kanagawa, Japan
TEL 0467461717
Homepage URL
Email futoshi-yamanaka@nifty.com

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

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 The Tokushukai Group Ethics Committee
Address Chiyodaku, Tokyo
Tel 03-3263-4801
Email 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
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 Completed
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
2015 Year 06 Month 08 Day
Anticipated trial start date
2015 Year 06 Month 16 Day
Last follow-up date
2018 Year 08 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing particular

Management information
Registered date
2017 Year 11 Month 01 Day
Last modified on
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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