UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038403 |
|---|---|
| Receipt number | 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 | 2023/05/01 09:50:53 |
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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 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
3) To investigate the diagnostic accuracy between post-PCI FFR and RI values
4) To investigate the clinical impact of post-PCI FFR and RI values
5) To investigate the relationship between angiographic findings and physiological indices (FFR and RI)
6) To investigate cutoff points of RI for predicting future clinical events
7) To establish the algorithm using FFR, RI, and QFR (quantitative flow ratio) for ischemic diagnosis
8) To investigate the relationship between CCTA (coronary computed tomographic angiography) findings and physiologic indices (FFR and RI)
9) To investigate cutoff points of FFR and RI for predicting future clinical events associated with non-culprit lesions in patients with acute coronary syndrome
10) To investigate cutoff points of FFR and RI for predicting future clinical events in patients with aortic stenosis
11) To investigate cutoff points of FFR and RI for predicting future clinical events in dialysis patients
12) To investigate the relationship between FFR and RI in terms of diagnostic accuracy and clinical outcomes according to cardiac function.
13) To investigate the relationship between hyperemic agents and clinical outcomes
14) To investigate the relationship between pressure-derived coronary flow reserve, FFR, and RI
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
matsuo@heart-center.or.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardio Vascular Clinic
Division name
Cardiovascular Medicine
Zip code
8028555
Address
North 49, East 16-1, Higashi Ward, Sapporo
TEL
0117847847
Homepage URL
kuramitsu@heart-kizuna.com
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
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
Sapporo Cardio Vascular Clinic
Address
North 49, East 16-1, Higashi Ward, Sapporo
Tel
0117847847
kuramitsu@heart-kizuna.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
| 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
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043585
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