Comparison of UFR With QFR in Stable Coronary Artery Disease

NCT06322355 | Completed

• 1 other identifier: ZSUFR01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Compare diagnostic performance of QFR with UFR

  baseline

Secondary Outcomes (1)

• Correlation and agreement between QFR and UFR

  baseline

Interventions

Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound DIAGNOSTIC_TEST

Invasive CAG was conducted following standard clinical procedures, encompassing multiple projections of both the left and right coronary arteries. The FFR was precisely measured using either an intracoronary pressure wire (Pressure Wire X; Abbott Vascular, Santa Clara, USA) or a rapid-exchange pressure microcatheter (Insight Lifetech, Shanghai, China) during peak hyperemia. This state of maximal hyperemia was achieved through the intravenous infusion of adenosine triphosphate (ATP) at a concentration of 150 μg/kg/min, administered via the forearm vein. Upon completion of the FFR assessment, the pressure wire or microcatheter was carefully retracted to the tip of the guiding catheter for a routine drift check. IVUS imaging was meticulously conducted using the iLab™ IVUS system, coupled with a 40-MHz OptiCross IVUS catheter (Boston Scientific, Fremont, USA), at a steady pullback speed of 0.5 mm/s.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants included in the study had at least one target lesion demonstrating 30% to 90% diameter stenosis, as visually estimated from CAG.

You may qualify if:

• Patients who underwent both IVUS imaging and FFR measurement on the same artery

You may not qualify if:

• Inadequate quality of CAG or IVUS images for QFR or UFR calculation
• Left main or ostial right coronary artery lesion
• The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging
• Incomplete IVUS pullback across the entire lesion segment
• The presence of a severe myocardial bridge (defined as ≥30% systolic diameter stenosis) in the examined vessel
• History of previous coronary artery bypass grafting,
• Left ventricular ejection fraction \<35%

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 210000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: March 21, 2024
• Study Start: July 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)