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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036571
Receipt No. R000041448
Scientific Title The efficacy of fractional flow reserve-guided percutaneous coronary intervention for patients with angina pectoris: A network meta-analysis
Date of disclosure of the study information 2019/04/24
Last modified on 2019/04/24

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Basic information
Public title The efficacy of fractional flow reserve-guided percutaneous coronary intervention for patients with angina pectoris: A network meta-analysis
Acronym The efficacy of fractional flow reserve-guided percutaneous coronary intervention for patients with angina pectoris: A network meta-analysis
Scientific Title The efficacy of fractional flow reserve-guided percutaneous coronary intervention for patients with angina pectoris: A network meta-analysis
Scientific Title:Acronym The efficacy of fractional flow reserve-guided percutaneous coronary intervention for patients with angina pectoris: A network meta-analysis
Region
Japan

Condition
Condition Angina pectoris
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm whether FFR-guided PCI improves prognosis compared to other treatments
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality
Key secondary outcomes Myocardial infarction

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The studies fulfilling the following criteria were included in the analyzes : randomized controlled trials ; studies including patients with AP as study participants; studies involving at least two treatments among FFR-guided PCI, CABG, non-FFR-guided PCI, and MT; and studies with all-cause mortality as an outcome, and studies had at least 1-year follow up period. FFR-guided PCI was defined as PCI for coronary artery stenosis with an FFR of 0.80 or less in the target vessel and non-FFR-guided PCI group was defined as PCI without FFR evaluation.
Key exclusion criteria Exclusion criteria were as follows: literature reviews or case reports, studies including participants requiring emergency intervention, studies including participants with myocardial infarction within 72 hours prior to enrollment
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Shinohara
Organization The University of Tokyo Hospital
Division name Department of Cardiovascular Medicine
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email hshinohara-gun@umin.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Shinohara
Organization The University of Tokyo Hospital
Division name Department of Cardiovascular Medicine
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email hshinohara-gun@umin.ac.jp

Sponsor
Institute Tokyo University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 None
Address None
Tel -
Email -@-

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 04 Month 24 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 16187
Results
The study included 16187 patients from 15 RCTs. Network meta analysis (NMA) showed that the all-cause mortality of FFR-guided PCI was not significantly different than those of the other treatment groups (CABG, OR 1.1, 95% CI 0.66, 1.7; non FFR guided PCI, OR 0.85, 95% CI 0.53, 1.4; and MT, OR 0.82, 95% CI 0.52, 1.3). The NMA for MI, including 13548 patients from 12 RCTs, showed that FFR guided PCI tended to reduce the occurrence of MI compared with MT (OR 0.60, 95% CI 0.36, 1.0).
Results date posted
2019 Year 04 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
All-cause mortality, Myocardial infarction.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 03 Month 08 Day
Date of IRB
2019 Year 03 Month 08 Day
Anticipated trial start date
2019 Year 03 Month 08 Day
Last follow-up date
2019 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multiple databases were searched for studies from 2000 to 2018, and a NMA was performed to compare outcomes with FFR guided PCI, non FFR guided PCI, CABG, and MT for AP based on estimated odds ratios. Treatments were ranked by the surface under the cumulative ranking curve.

Management information
Registered date
2019 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041448

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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