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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038403
Receipt No. R000043585
Scientific Title Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Resting Indices and Fractional Flow Reserve: A Prospective Multicenter Registry
Date of disclosure of the study information 2019/11/01
Last modified on 2019/11/02

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Basic information
Public title Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Resting Indices and Fractional Flow Reserve: A Prospective Multicenter Registry
Acronym J-PRIDE Registry
Scientific Title Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Resting Indices and Fractional Flow Reserve: A Prospective Multicenter Registry
Scientific Title:Acronym J-PRIDE Registry
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess clinical outcomes of discordant cases between FFR and resting indices in patients with coronary artery disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare 1-year TVF (target vessel failure) rate between four groups: (I) FFR <=0.80 and RI >0.89, (II) FFR >0.80 and RI <=0.89, (III) FFR >0.80 and RI >0.89, and (IV) FFR <=0.80 and RI <=0.89
Key secondary outcomes (1) To assess the feasibility of dPR, RFR, and DFR as compared with FFR and iFR
(2) To assess the relationship between RI and angiographic findings
(3) To compare 5-year TVF (target vessel failure) rate between four groups: (I) FFR <=0.80 and RI >0.89, (II) FFR >0.80 and RI <=0.89, (III) FFR >0.80 and RI >0.89, and (IV) FFR <=0.80 and RI <=0.89

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) Patients were clinically suspected of angina pectoris and underwent coronary angiography (CAG).
(3) CAG showed more than 50% stenosis by visual estimation.
(4) Both FFR and resting indices were performed to assess functional significance of coronary artery lesion.
(5) Cases with iFR, RFR, dFR, or DFR as resting indices.
Key exclusion criteria (1) culprit lesion of acute coronary syndrome
(2) graft lesion
(3) overt heart failure
(4) inability to give informed consent
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Hotoshi
Middle name
Last name Matsuo
Organization Gifu Heart Center
Division name Cardiology
Zip code 5008384
Address 4-14-4 Yabutaminami, Gifu
TEL 0582772277
Email matsuo@heart-center.or.jp

Public contact
Name of contact person
1st name Shoichi
Middle name
Last name Kuramitsu
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code 8028555
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu
TEL 0935112000
Homepage URL
Email kuramitsu@circulation.jp

Sponsor
Institute Gifu Heart Center
Institute
Department

Funding Source
Organization None
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 Kokura Memorial Hospital
Address 3-2-1 Asano, Kokurakita-ku, Kitakyushu
Tel 0935112000
Email kuramitsu@circulation.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
2019 Year 11 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 Enrolling by invitation
Date of protocol fixation
2019 Year 08 Month 23 Day
Date of IRB
2019 Year 08 Month 28 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2019 Year 10 Month 28 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043585

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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