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Recruiting NCT07669987

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

Observational Quantitative Flow Reserve Minimally Invasive Coronary Surgery Radial Artery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational.
Who it may be relevant to
Registry conditions: Quantitative Flow Reserve, Minimally Invasive Coronary Surgery, Radial Artery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Observational
    Observational study

Primary outcome measures

  • The patency of the graft vessels one year postoperatively. [Time frame: 12 months]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking university third hospital — Beijing

Identifiers

NCT: NCT07669987 · QFR-RADIAL · BYSYZD2023015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗