Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study

Coronary Artery Disease Clinical Trial

— CAREER  

Official title:

Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665817
• Other study ID #: Huadong Hospital
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Fudan University
• Contact: Xinkai Qu, MD,PhD
• Phone: +86 13916320399
• Email: qxkchest[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.

Description:

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Coronary CT angiography indicates that >= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel >= 2mm.

2. The invasive coronary angiography should be less than 30 days after the coronary CT angiography.

Exclusion Criteria:

1. The target lesion has received coronary stent implantation or coronary artery bypass graft.

2. Target lesion involves myocardial bridge.

3. Severe heart failure (NYHA =III).

4. Renal function is seriously damaged (eGFR<30 ml/min/1.73m2).

5. Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.

6. Acute myocardial infarction within 1 month.

7. The image quality of CTA or coronary angiography cannot be assessed.

8. Any factors that affect the image quality of coronary CTA and coronary angiography, such as frequent premature contractions, atrial fibrillation, etc.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Computed Tomography Angiography
• Coronary Stenosis
• Hemodynamics

Intervention

Diagnostic Test:
• CT-QFR
CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images.
• QFR
QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections.
• FFR
FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis.

Locations

Country	Name	City	State
China	Xinkai Qu	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of CT-QFR	Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard.; Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year
Secondary	Comparision between CT-QFR and QFR	Use FFR as a reference standard to validate the non-inferiority of CT-QFR compared with QFR in the vessels without extensively calcified lesions defined by the combination of a cross-sectional calcium arc >90° and a thickness >1.5 mm. For CT-QFR, QFR and FFR evaluations, vessels with <=0.80 are regarded as having hemodynamically significant CAD.	1.5 year
Secondary	Other common measures of diagnostic performance of CT-QFR	Other common measures of diagnostic performance of CT-QFR, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the patient level compared with FFR as the reference standard.; Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year
Secondary	Correlation between CT-QFR and FFR	Pearson correlation or spearman's correlation will be used to quantify the correlations between CT-QFR and FFR. Agreements between CT-QFR and FFR will be assessed by Bland-Altman plot.; The correlation coefficient r=0-0.2 represents very weak or no correlation. 0.2-0.4 represents weak correlation. 0.4-0.6 represents moderate correlation. 0.6-0.8 represents strong correlation. 0.8-1.0 represents very strong correlation.	1.5 year
Secondary	The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%	The comparison of the discrimination ability between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%), and QCA-derived DS% for identifying physiologically significant stenosis with FFR as the reference standard.; Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year