Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665817
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2020-12-07
Brief Title:
Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio CAREER Study
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAREER
Brief 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
Detailed Description:
This study is a prospective and single-center trial in ChinaIt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None