Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency
Brief summary
Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.
Detailed description
CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.
Interventions
PROCEDUREQFR-guided CABG
CABG surgery based on CAG and QFR
PROCEDUREAngio-guided CABG
CABG surgery based on heart team discussion of CAG
Sponsors
Beijing Municipal Science & Technology Commission
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with evidence of angina pectoris * left main or three vessels disease, have the indication for CABG after discussion of the heart team * at least one main vessels stenosis on 40%-70%
Exclusion criteria
* former cardiac surgery patients * need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy * emergent CABG * acute myocardial infarction time less than 7 days * life expectancy less than 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of graft patency | 12 months | graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular event(MACE) | 12 months | The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization |
| The rate of angina relief | 12 months | whether angina is relieved will be evaluated |
Countries
China
Contacts
Primary ContactYang Zhao, MD
Outcome results
None listed