A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation (QFR-REAL)

August 11, 2026 updated by: China National Center for Cardiovascular Diseases

This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.

Study Overview

Status

Not yet recruiting

Conditions

Coronary Artery Disease

Detailed Description

This is a prospective, multicenter, observational registry study conducted at more than 50 centers across China. Patients with coronary angiography showing visually estimated at least one main branch stenosis ≥50% who undergo PCI or receive conservative treatment for 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) will be consecutively enrolled. Coronary angiographic images will be submitted to an independent core laboratory for retrospective QFR analysis. The study will establish a QFR-based quality control standard system for coronary revascularization.

Prespecified subgroup analyses will be performed to assess the concordance rates, overtreatment, and undertreatment rates between clinical decisions and offline core laboratory QFR, and to explore heterogeneity across hospital levels, clinical presentations, disease complexity, target vessel, operator annual PCI volume, QFR image analyzability, and lesion morphology. Other prespecified subgroups will be analyzed for the primary and secondary endpoints, including age, sex, diabetes, smoking status, acute coronary syndrome, body mass index, left ventricular ejection fraction, lesion location, length and reference vessel diameter, stenosis severity, multivessel disease, calcified lesion, bifurcation, tandem and bending/tortuous lesion, QFR gray zone (0.75-0.85), QFR based functional and residual functional SYNTAX score, residual QFR, center experience for invasive physiology, and learning experience with QFR.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jie Qian, PhD
Phone Number: 010-88396089
Email: qianjfw@163.com

Study Locations

China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100037
    - National Clinical Research Center of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    - Contact:
      
      Fuwai hospital
      
      Phone Number: 010-88322674
      
      Email: kyy1220@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% who present with asymptomatic ischemia, stable angina, unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction (>4 weeks after onset) and undergo PCI or receive conservative treatment at one of the participating centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QFR Adoption Rate Time Frame: At enrollment (baseline)	Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.	At enrollment (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE Time Frame: 6 month, 1 year, 3 years, and 5 years	A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization	6 month, 1 year, 3 years, and 5 years
Death Time Frame: 6 months, 1 year, 3 years, and 5 years	Cardiovascular, non-cardiovascular and undetermined death	6 months, 1 year, 3 years, and 5 years
MI Time Frame: 6 months, 1 year, 3 years, and 5 years	Target vessel related and non-target vessel related MI	6 months, 1 year, 3 years, and 5 years
Target vessel revascularization (TVR) Time Frame: 6 months, 1 year, 3 years, and 5 years	The ischemia driven and non-ischemia driven TVR	6 months, 1 year, 3 years, and 5 years
Any coronary artery revascularization Time Frame: 6 months, 1 year, 3 years, and 5 years	The ischemia driven and non-ischemia driven Revascularization	6 months, 1 year, 3 years, and 5 years
Definite or probable stent thrombosis Time Frame: 6 months, 1 year, 3 years, and 5 years	Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase according to the Academic Research Consortium (ARC)-2	6 months, 1 year, 3 years, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Guangdong Provincial People's Hospital

Sir Run Run Shaw Hospital

Second Hospital of Jilin University

Fuwai Yunnan Cardiovascular Hospital

Fuwai Huazhong Cardiovascular Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)