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

Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis: a Prospective, Multicenter Clinical Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04493086
Enrollment
500
Registered
2020-07-30
Start date
2020-10-01
Completion date
2021-12-31
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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.

Detailed description

Cardiovascular disease remains the leading cause of death worldwide, and stable coronary artery disease (SCAD) accounts for the greatest proportion of cardiovascular disease. In the past decades, percutaneous coronary intervention (PCI) has become one of the most common treatments for SCAD, and therefore assessing the hemodynamic significance of coronary stenosis is important for physicians to make the optimal treating strategy. 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. FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study confirmed that FFR guided PCI was superior to angiography guided PCI in reducing major adverse cardiovascular events (MACE) in patients with multivessel disease. In the subsequent FAME 2 study, FFR guided PCI plus the optimal medical treatment (OMT), as compared with the OMT alone, decreased the composite event rates mainly driven by urgent revascularization in SCAD patients. 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.

Interventions

DIAGNOSTIC_TESTFFRCT-angio

According to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR \< 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard.

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients with stable coronary heart disease undergoing CTA. * Patients with at least one coronary artery stenosis of 50% - 90% in diameter ≥ 2mm. * Within 30 days after CTA, CAG and FFR were determined by clinicians according to their condition.

Exclusion criteria

* Patients with myocardial infarction within 72 hours. * Patients with coronary artery thrombosis. * Patients with a history of allergy to contrast media or adenosine. * NYHA class III-IV patients. * Patients with previous CABG, target vessel PCI, pacemaker, ICD. * Patients with a history of prosthetic valve implantation. * Patients with myocardial bridges in the target vessels. * Patients with severe arrhythmia.

Design outcomes

Primary

MeasureTime frameDescription
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis5 daysBy taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis

Secondary

MeasureTime frameDescription
By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis5 daysBy taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis

Countries

China

Contacts

Primary ContactYue Li, PhD
ly99ly@vip.163.com86-451-85552216
Backup ContactJingyi Xue, PhD
xuejingyi72@163.com86-451-85555672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026