The Impact of Preoperative Quantitative Flow Reserve (QFR) on Early Postoperative Radial Artery Graft Outcomes in Coronary Artery Bypass Grafting

NCT07669987 | Recruiting DMC

• 2 other identifiers: QFR-RADIALBYSYZD2023015
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of Quantitative Flow Reserve (QFR) assessment in patients undergoing Coronary Artery Bypass Grafting (CABG). The main question it aims to answer is: Does preoperative QFR measurement improve graft outcomes and reduce major adverse cardiac and cerebrovascular events (MACE) in patients undergoing CABG? Participants who are scheduled for CABG and have undergone preoperative QFR assessment will be followed for one year post-surgery. They will provide data on graft patency and report any occurrences of MACE through regular follow-up visits and questionnaires about their health status.

Conditions

Quantitative Flow Reserve; Minimally Invasive Coronary Surgery; Radial Artery

Keywords

Quantitative Flow Reserve; minimally invasive coronary surgery; Radial Artery

Outcome Measures

Primary Outcomes (1)

• The patency of the graft vessels one year postoperatively.

  The patency of the radial artery graft in subjects who underwent coronary artery bypass grafting (CABG) one year postoperatively was assessed using coronary computed tomography angiography (CCTA) or conventional angiography (CAG), and its functional status was evaluated. Patency was classified according to the FitzGibbon classification system: Grade A indicates widely patent grafts, Grade B indicates grafts with limited flow (stenosis \< 50%), Grade S denotes the presence of string sign (stenosis \> 50% at any location of the graft), and Grade O signifies graft occlusion. Grades S and O were considered indicative of graft failure. The angiographic/CTA evaluations were conducted by two clinical physicians who were blinded to the preoperative quantitative flow ratio (QFR) values.

  12 months

Secondary Outcomes (1)

• The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at one year post-surgery, including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization.

  12 months

Interventions

Observational OTHER

Observational study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This project aims to prospectively enroll patients undergoing coronary artery bypass grafting (CABG) utilizing the radial artery as a conduit at Peking University Third Hospital from January 2023 to September 2025.

You may qualify if:

• Patients aged 18 to 80 years.
• Patients whose angina pectoris significantly affects daily life and work, and for whom conservative medical treatment is ineffective, requiring coronary artery bypass grafting (CABG).
• Preoperative coronary angiography data are available for quantitative flow ratio (QFR) analysis.
• Patients with severe stenosis, defined as greater than 70% stenosis, in the three main coronary artery branches, including the left anterior descending artery, circumflex artery, and right coronary artery, with or without left main coronary artery stenosis greater than 50%.

You may not qualify if:

• Patients who cannot tolerate CABG due to comorbidities or complications.
• Patients requiring urgent CABG or percutaneous coronary intervention (PCI).
• Patients with significant congestive heart failure or hemodynamic instability.
• Patients with a history of previous CABG or PCI within the past 6 months.
• Patients who have experienced a stroke within the past 6 months.
• Patients requiring concurrent cardiac procedures, such as valve surgery, maze surgery, radiofrequency ablation, or pacemaker implantation.
• Patients with allergies to contrast agents or antiplatelet medications, or with contraindications to antiplatelet medications due to bleeding risks.
• Patients with a significant history of bleeding, marked leukopenia, neutropenia, thrombocytopenia, anemia, or bleeding diathesis.
• Patients currently participating in other prospective clinical studies.
• Patients who are unwilling to participate in this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Tong Ding, MD

CONTACT

+8613132150173; dt1067723747@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: June 25, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)