UMIN-CTR Clinical Trial

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

coronary artery diseases

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Gifu Heart Center

Institute

Department

Personal name

Organization

Siemens Healthcare GmbH

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gifu Heart Center

Address

4-14-4 Yabuta-Minami, Gifu

Tel

058-277-2277

Email

inada@heart-center.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岐阜ハートセンター（岐阜県）

Date of disclosure of the study information

2020

Year

09

Month

07

Day

URL releasing protocol

NA

Publication of results

Published

URL related to results and publications

Circulation journal in press

Number of participants that the trial has enrolled

200

Results

We assessed continuous 253 vessels from 200 patients. Accuracy of the angioFFR was 87.7% (95% confidence interval (CI) 83.1to 91.5), sensitivity was 76.8% (95% CI 67.1to 84.9), and specificity was 94.3% (95% CI 89.5 to 97.4). AngioFFR had a good correlation with invasive FFR (r = 0.76, 95% CI 0.71to 0.81, p<0.001). The agreement between both methods was 0.003 (limits of agreement -0.13 to 0.14). The area under the curve of angioFFR was 0.90 (95% CI 0.86 to 0.93).

Results date posted

2021

Year

09

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The patients were 71 years old and included 143 (71.5%) men. Of the 253 vessels analyzed, tandem lesions, bifurcation lesions, heavy calcification, and severe tortuous vessels accounted for 69 (27.3%), 88 (34.8%), 17 (6.7%), and 23 (9.1%) of the lesions, respectively.

Participant flow

A total of 293 consecutive vessels with 30% to 90% angiographic stenoses were enrolled and all patients were measured invasive FFR. We excluded 33/293 (11.3%) vessels (26/232 (11.2%) patients) with 3/293 (1.0%) left main trunk disease, 6/293 (2.0%) ostial lesions, 16/293 (5.5%) severe aortic valve stenosis, and 8/293 (2.7%) measured vessels with collaterals. In an offline analysis, we excluded 7/293 (2.4%) vessels (6/232 (2.6%) patients) with 3/293 (1.0%) unclear images due to insufficient contrast, 1/293 (0.3%) overlapped lesion, and 3/293 (1.0%) severe tortuous vessels that precluded contour detection. Finally, we analyzed 253/293 (86%) vessels (200/232 (86%) patients)

Adverse events

NA

Outcome measures

The primary endpoint was the accuracy of the angioFFR using invasive FFR equal or less than 0.80 as the reference standard. The secondary endpoints included the sensitivity, specificity, positive predictive value, and negative predictive value of the angioFFR. The correlation, the agreement, and the area under the curve (AUC) of the receiver operating characteristics (ROC), as well as the gradients between the invasive FFR and angioFFR were also estimated as well as the accuracy of the average diameter between the intracoronary imaging and the angioFFR console, and the reproducibility of the angioFFR

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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

2020

Year

04

Month

02

Day

Date trial data considered complete

2020

Year

04

Month

02

Day

Date analysis concluded

2022

Year

09

Month

01

Day

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.

Registered date

2020

Year

09

Month

07

Day

Last modified on

2023

Year

03

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047612