Coronary Artery Disease Clinical Trial
— ASRAB-QUARGOOfficial title:
Impact of Preoperative Quantitative Flow Ratio on Radial Artery Graft Outcome After Coronary Artery Bypass Grafting in the ASRAB-Pilot Trial
NCT number | NCT05556590 |
Other study ID # | KY-2022144 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 9, 2022 |
Est. completion date | April 30, 2023 |
Verified date | July 2023 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In coronary artery bypass grafting (CABG), the use of radial artery (RA) is recommended by the guidelines only to significantly stenosed vessel, due to its high vulnerability to competitive flow. Fractional flow reserve (FFR) is the gold standard to measure physiological significance of coronary lesions and the potential for competitive flow. This study aims to investigate whether the preoperative quantitative flow ratio (QFR) measurement, a novel coronary angiography-based FFR, is associated with RA graft failure post-CABG, and to explore the best cut-off value of QFR for RA grafts using. Patients from ASRAB-pilot trial (NCT04310995) undergoing primary isolated CABG using RA grafts, and with preoperative coronary angiography (CAG) images available for QFR analysis will be enrolled in this prospective double-blind observational study. QFR analysis will be conducted for all RA-grafted vessels based on preoperative CAG. The primary outcome will RA graft failure (FitzGibbon Grade B,O or S) evaluated by coronary computer tomography angiography or CAG at 7 days and 6 months post-CABG.
Status | Completed |
Enrollment | 135 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients enrolled in the ASRAB-pilot study. Exclusion Criteria: - Preoperative CAG not available for QFR analysis. The inclusion and exclusion criteria of ASRAB-pilot study are attached: Inclusion Criteria: - Age=18 years. - Male or female patients. - Have signed informed consent. - Have successfully accepted the first RA-CABG surgery. Exclusion Criteria: - Previously experienced an allergy to active ingredients and/or excipients of experimental drugs. - Hypotension (defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg) after surgery. - Acute myocardial infarction, pulmonary congestion or cardiogenic shock after surgery. - Concomitant medications with phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc. - Pathological sinus node syndrome, degree II or III atrioventricular block without cardiac pacemaker. - Contraindications for coronary computed tomography angiography (CCTA) or coronary arteriography (CAG) examination, such as iodine allergy, etc. (note: patients with renal insufficiency or even end-stage renal disease whose hemodialysis can be tolerated by CCTA or CAG tests are eligible for inclusion). - History or evidence of ongoing alcohol or drug abuse. - Life expectancy < 1 year judged by investigators. - Other inappropriate situations judged by investigators. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-month radial artery graft failure | Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure. | 6 months after surgery | |
Primary | 7-day radial artery graft failure | Graft outcome will be evaluated by CCTA or CAG according to the Fitzgibbon classification criteria: Grade A, grade B, grade O and grade S (String Sign). Grade B, O and S are considered as graft failure. | 7 days after surgery | |
Secondary | Major adverse cardiovascular event (MACE) | MACE is defined as a composite of all-cause death, myocardial infarction, stroke and unplanned coronary revascularization. The first occurring MACE or its component, as well as the time of occurrence, is collected. | within 6 months after surgery | |
Secondary | Myocardial infarction related to radial artery graft failure | Defined as new wall motion abnormalities detected by echocardiogram, or new Q wave detected by electrocardiograph (ECG) in the region grafted with radial artery. | within 6 months after surgery | |
Secondary | Unplanned coronary revascularization related to radial artery graft failure | Subjects may receive unplanned revascularization to the territory originally grafted by radial artery graft, either by PCI or CABG. This is defined as an "unplanned coronary revascularization related to radial artery graft failure" event. | within 6 months after surgery |
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