UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036571 |
|---|---|
| Receipt number | 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 11:33:14 |
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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
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
hshinohara-gun@umin.ac.jp
Sponsor or person
Institute
Tokyo University
Institute
Department
Personal name
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
-
-@-
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041448
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| Registered date | File name |
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