NCT04493086

Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis

Status unknown Last updated 30 July 2020

What this trial tests

trial testing FFRCT-angio in Coronary Artery Disease in 500 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
1 October 2021

31 December 2021

Quick facts

Lead sponsor	First Affiliated Hospital of Harbin Medical University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 October 2020
Primary completion	1 October 2021
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• FFRCT-angio

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

First Affiliated Hospital of Harbin Medical University

Who can join

Adults 18 to 90, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD. However, the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries.

As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel. The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI should be considered if FFR≤0.80. However, FFR does have some limitations, such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic agents.

To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is relatively low in lesions with severe calcification and/or tortuosity. Besides, the methodology of FFRCT relies on computational fluid dynamics, which is complicated and time consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis. The accuracy of QFR is also highly associated with anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem, thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior infarction-related or collateral donor arteries as well. Given the above issues concerning FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.