Multicenter Registry for Angiography-Derived Quantitative Flow Ratio

Ischemic Heart Disease Clinical Trial

— QFRRegistry  

Official title:

Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791788
• Other study ID #: QFR2018-11-112-002
• Status: Completed
• Start date: April 30, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be =18 years
• Patients suspected with ischemic heart disease
• Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
• Patients who were able to analyze QFR
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides

Exclusion Criteria:

• Left main (LM) or right coronary artery (RCA) ostial lesion
• Severe overlap of stenotic segments
• Severe tortuosity of target vessel
• Poor angiographic image quality precluding contour detection
• No optimal images with angles = 25o

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• QFR assessment
QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Samsung Medical Center	Chosun University Hospital, Dongsan Medical Center, Inje University, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-specified substudy of exercise duration after PCI	residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization.; Pre- and Post-PCI exercise treadmill test within 3 months window from PCI	through study completion, an average of 3 months
Primary	Diagnostic accuracy of QFR	Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8	through study completion, an average of 6 months
Primary	Vessel-related composite outcome	a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization	through study completion, an average of 2 year
Secondary	Sensitivity of QFR	Sensitivity of contrast QFR to predict FFR lower than 0.8	through study completion, an average of 6 months
Secondary	Specificity of QFR	Specificity of contrast QFR to predict FFR lower than 0.8	through study completion, an average of 6 months
Secondary	Correlation between QFR and FFR	Correlation between QFR and FFR	through study completion, an average of 6 months