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NCT Number: NCT07669987

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Tong Ding

CONTACT

[email protected]

13132150173

Yunpeng Ling, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

Observational

Other

Observational study

Primary outcomes

  1. The patency of the graft vessels one year postoperatively.

    Time frame: 12 months

    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.

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.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Tong Ding, MD

CONTACT

[email protected]

+8613132150173

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Acronym: QFR-RADIAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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