Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 30, 2020
July 1, 2020
1 year
July 28, 2020
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
5 days
Secondary Outcomes (1)
By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
5 days
Interventions
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.
Eligibility Criteria
Patients with stable coronary heart disease
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 30, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 31, 2021
Last Updated
July 30, 2020
Record last verified: 2020-07