Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03791788
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2018-12-28
Brief Title:
Multicenter Registry for Angiography-Derived Quantitative Flow Ratio
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
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:
QFRRegistry
Brief Summary:
1 to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio QFR for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease CAD including presentation of acute myocardial infarction AMI with non-culprit lesion
2 to compare the changes of contrast QFR and fractional flow reserve FFR according to severity of percent diameter stenosis DS
3 to evaluate prognostic implication of contrast QFR in comparison with FFR
2 to compare the changes of contrast QFR and fractional flow reserve FFR according to severity of percent diameter stenosis DS
3 to evaluate prognostic implication of contrast QFR in comparison with FFR
Detailed Description:
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention PCI adoption rate of FFR is still low in real world practice most likely due to use of additional resource and to concern about side effects of hyperemic agent Therefore several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations One of the novel methods the contrast quantitative flow ratio QFR is a computation of FFR based on 3-dimensional quantitative coronary angiography QCA combined with Thrombolysis in Myocardial Infarction TIMI frame counts adjustment without hyperemic agent infusion
Although diagnostic performance of contrast QFR for evaluation of functional significance using FFR as reference standard is well validated in patients with stable ischemic heart disease SIHD there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI
Therefore the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD In addition prognostic implication of contrast QFR will be also compared with that of FFR
Although diagnostic performance of contrast QFR for evaluation of functional significance using FFR as reference standard is well validated in patients with stable ischemic heart disease SIHD there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI
Therefore the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD In addition prognostic implication of contrast QFR will be also compared with that of FFR
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