Coronary Artery Disease
Conditions
Keywords
Quantitative Coronary Angiography, Quantitative Flow Ratio, Percutaneous Coronary Intervention, Myocardial Ischaemia
Brief summary
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.
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.
Interventions
None listed
Sponsors
China National Center for Cardiovascular Diseases
Guangdong Provincial People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
Sir Run Run Shaw Hospital
Fuwai Huazhong Cardiovascular Hospital
Fuwai Yunnan Cardiovascular Hospital
Second Hospital of Jilin University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QFR Adoption Rate | At enrollment (baseline) | Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 6 month, 1 year, 3 years, and 5 years | A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization |
| Death | 6 months, 1 year, 3 years, and 5 years | Cardiovascular, non-cardiovascular and undetermined death |
| MI | 6 months, 1 year, 3 years, and 5 years | Target vessel related and non-target vessel related MI |
| Target vessel revascularization (TVR) | 6 months, 1 year, 3 years, and 5 years | The ischemia driven and non-ischemia driven TVR |
| Any coronary artery revascularization | 6 months, 1 year, 3 years, and 5 years | The ischemia driven and non-ischemia driven Revascularization |
| Definite or probable stent thrombosis | 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 |
Countries
China
Contacts
CONTACTJie Qian, PhD
Outcome results
None listed