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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041712
Receipt No. R000047612
Scientific Title Rapid Assessment of Precise Ischemic Diseases using angioFFR based on AI study
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title Diagnostic Performance of Angiography-derived Fractional Flow Reserve
Based on Artificial Intelligence
Acronym Diagnostic Performance of AngioFFR
Scientific Title Rapid Assessment of Precise Ischemic Diseases using angioFFR based on AI study
Scientific Title:Acronym RAPID FFR study
Region
Japan

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

Objectives
Narrative objectives1 The present study aims to assess the diagnostic performance and the processing time of angioFFR to detect hemodynamically relevant coronary artery diseases (CAD) using invasive FFR as a reference standard.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Accuracy of angioFFR using invasive FFR less than or equal to 0.80 as the reference standard.
Key secondary outcomes Sensitivity, specificity, positive predictive value and negative predictive value of angioFFR; the correlation, the agreement the area under the curve (AUC) of receiver-operating characteristics (ROC), the gradients and the processing time between invasive FFR and angioFFR; accuracy of average diameter and cross-section areas between the intracoronary imaging and angioFFR console; and reproducibility of angioFFR.

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who had CAD with angiographically 30%-90% stenoses in major epicardial vessels were included
Key exclusion criteria Coronary artery bypass grafting, myocardial infarction <72 hours, left main trunk disease, ostial lesions, vessel with stents, severe aortic valve stenosis and measured vessels with collaterals were excluded
Target sample size 200

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 Siemens Healthcare GmbH
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
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)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 07 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 200
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 23 Day
Date of IRB
2018 Year 05 Month 23 Day
Anticipated trial start date
2018 Year 11 Month 05 Day
Last follow-up date
2020 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this prospective, single center study, all patients who were referred to angiography for suspected CAD with invasive FFR were included. AngioFFR was calculated from two angiographic projections of at least 30 degree difference in angulation. Diagnostic performance of angioFFR was assessed using invasive FFR as reference standard. The processing time were compared between invasive FFR and angioFFR. In percutaneous coronary intervention (PCI) cases, the pre-PCI FFR gradient was assessed. The indication for performing PCI and pre-stenting segments were based on the attending physicians discretion using nadir FFR value and FFR pullback. Gradients of invasive FFR and angioFFR were defined as the difference of invasive FFR and angioFFR respectively between the proximal and distal edges of the pre-stenting segments.
Moreover, accuracy of average diameter and cross-section areas derived from angioFFR console were compared to pre-PCI invasive intracoronary imaging at minimum lumen site. The intracoronary imaging were intravascular ultrasound.

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047612

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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