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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

QFR Adoption Rate

Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.

Time frame
At enrollment (baseline)

Secondary outcomes

1

MACE

A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization

Time frame
6 month, 1 year, 3 years, and 5 years
2

Death

Cardiovascular, non-cardiovascular and undetermined death

Time frame
6 months, 1 year, 3 years, and 5 years
3

MI

Target vessel related and non-target vessel related MI

Time frame
6 months, 1 year, 3 years, and 5 years
4

Target vessel revascularization (TVR)

The ischemia driven and non-ischemia driven TVR

Time frame
6 months, 1 year, 3 years, and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Guangdong Provincial People's Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Fuwai Huazhong Cardiovascular Hospital

Collaborator

Fuwai Yunnan Cardiovascular Hospital

Collaborator

Second Hospital of Jilin University

Collaborator