UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033534
Receipt No. R000038237
Scientific Title Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR
Date of disclosure of the study information 2018/08/01
Last modified on 2020/11/10 (Ver. 11)

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Basic information
Public title Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR
Acronym Correlation between predictive value and post PCI value of iFR, RFR and dPR
Scientific Title Study to examine correlation between predictive value and post PCI value of iFR, RFR and dPR
Scientific Title:Acronym Correlation between predictive value and post PCI value of iFR, RFR and dPR
Region
Japan

Condition
Condition Stable coronary diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the difference and correlation between predictive value of iFR, RFR and dPR; average predictive value and post PCI value of iFR, RFR and dPR
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the difference and correlation between predictive value of iFR, RFR and dPR; average predictive value and post PCI value of iFR, RFR and dPR
Key secondary outcomes 1) Evaluate separately by Type A, B, C (tandem lesion, diffuse lesion)
2) Comparison of measurement time of RFR and dPR compared to iFR
3) Drift of each pressure wire
4) Proportion of 0.9 or more for post iFR, post RFR and post dPR; whether additional treatment was done
5) Whether post FFR achieves 0.8 or more. Whether additional treatment was done
6) Evaluation of plaque properties with IVUS (Terumo,Boston,NIPRO) of fiber component, lipid component, calcification. In particular, the predictive value when highly calcified at least 270 degrees of calcification is observed is not significantly different from the post PCI value.
7) Number of stents used and stent length

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The group (iFR group) which measured predictive value and post PCI value by iFR
Interventions/Control_2 The group (RFR group) which measured predictive value and post PCI value by RFR
Interventions/Control_3 The group (dPR group) which measured predictive value and post PCI value by dPR
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient who is scheduled to undergo CAG and iFR, RFR or dPR is positive (0.89 or less) and PCI is planned
Key exclusion criteria Bypass patients. ATP, nicorandil, papaverin contraindicated patients. STEMI. TIMI flow grade <3.90% < stenosis
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Matsuo
Organization Gifu Heart Center
Division name Department of Cardiovascular Medicine
Zip code 500-8384
Address 4-14-4 Yabuta-Minami, Gifu, Japan
TEL 058-277-2277
Email matsuo@heart-center.or.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Omori
Organization Gifu Heart Center
Division name Department of Cardiovascular Medicine
Zip code 500-8384
Address 4-14-4 Yabuta-Minami, Gifu, Japan
TEL 058-277-2277
Homepage URL
Email omori@heart-center.or.jp

Sponsor
Institute Gifu Heart Center
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyohashi Heart Center. Nagoya Heart Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gifu Heart Center
Address 4-14-4 Yabuta-Minami, Gifu
Tel 058-277-2277
Email inada@heart-center.or.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 岐阜ハートセンター（岐阜県）、豊橋ハートセンター（愛知県）、名古屋ハートセンター（愛知県）

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 Day

Related information
URL releasing protocol https://www.jacc.org/doi/10.1016/j.jcin.2020.06.060?fbclid=IwAR2u6J0ZyPl3Llb5Kq9wxU91p98hEeImBYlnm-W
Publication of results Published

Result
URL related to results and publications https://www.jacc.org/doi/10.1016/j.jcin.2020.06.060?fbclid=IwAR2u6J0ZyPl3Llb5Kq9wxU91p98hEeImBYlnm-W
Number of participants that the trial has enrolled 150
Results 
The pre-PCI predicted NHPRs had strong correlations with actual post-PCI NHPRs. The agreements be-tween pre-PCI predicted and actual post-PCI NHPRs were 0.02 for iFR, 0.01 for RFR, 0.02 for dPR, respectively.The number and the total length of treated lesions were lower in the NHPR pullback- than in the angiography-guided strategy. Actual post-PCI NHPRs had a poor correlation to the difference between angiography- and NHPR pullback-guided strategies
Results date posted
2020 Year 11 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The mean age of the patients was 71 years, and 108 (77%) were men.　The lesions were located most frequently in the left anterior descending artery (100 vessels (66.7%)). The NHPR groups had no significant differences in patient and lesion characteristics.
Participant flow 
Patients with stable coronary artery disease which were defined as having angiographically 40%-90% stenosis and NHPRs less than or equal 0.89 in major epicardial vessels, were included.Vessels were randomly assigned, in a 1:1:1 ratio, to receive iFR, RFR, or dPR pullback, without stratification factors.
Adverse events 
The procedures were performed successfully in all cases without any adverse events or complications.
Outcome measures 
The primary endpoint was to assess the relevance between pre-PCI predicted and actual post-PCI NHPRs. The secondary endpoints were to assess the reduction of the number and the total length of treated lesions based on the NHPRs pullback-guided PCI compared with angiography-guided PCI, in terms of procedural benefits.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 07 Month 24 Day
Date of IRB
2018 Year 07 Month 25 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 27 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038237