QFR-Guided Heart Revascularization Quality Registry in CAD
Official title: A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation
Run by China National Center for Cardiovascular Diseases · NCT07766434 · Data updated 2026-11-12
This registry tests whether using quantitative flow ratio (QFR) to guide coronary revascularization decisions across many centers can standardize quality in patients with coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 26, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2029 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07766434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with visually estimated ≥50% stenosis in a main coronary branch undergoing PCI or conservative management for acute or chronic coronary syndrome.
✕Probably not a fit
Patients with recent ST-elevation MI within 4 weeks, prior CABG planned within 6 months, or inability to undergo coronary angiography may have limited applicability or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational registry enrolling over 10,000 patients from more than 50 centers in China who have at least one main-branch coronary stenosis of 50% or more. Images from coronary angiography, and intracoronary imaging if available, will be collected and analyzed retrospectively by an independent core laboratory to establish a QFR-based quality control standard for revascularization. Subgroup analyses will explore how concordance between clinical decisions and QFR results varies by hospital level, presentation, disease complexity, lesion characteristics, operator volume, and image quality. The primary endpoint is the accessibility of QFR, represented by the mean usage proportion across centers. The study will include adults with acute or chronic coronary syndromes and will follow participants as per observational registry norms.
Why it matters
Potential benefit: If successful, the registry could enable more consistent, QFR-guided decision-making to improve revascularization quality and patient outcomes.
How similar studies have gone: Previous work in image-based and QFR-guided assessments suggests potential for improving decision quality, though this exact large-scale, multicenter registry is novel in scope.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% in patients with acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction \>4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) who undergo PCI or receive conservative treatment * Ability to understand the study design and provide written informed consent Exclusion Criteria: * ST-segment elevation myocardial infarction within 4 weeks of onset * History of coronary artery bypass grafting (CABG) or planned CABG within 6 months * Inability to undergo coronary angiography * Non-cardiac cause with expected survival \<1 year * Other conditions that may interfere with follow-up (e.g., dementia, substance abuse including drug addiction and other drug dependencies) * Refusal to participate in the study
Where it's running
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National Clinical Research Center of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jie Qian, PhD
- Email: qianjfw@163.com
- Phone: 010-88396089
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.