Coronary Artery Bypass Graft Surgery (CABG), Graft Failure, Radial Artery Grafts
Conditions
Keywords
CABG, Radial artery grafts, Isosorbide Mononitrate, Amlodipine
Brief summary
The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG. The main question it aims to answer is: Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG . Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works. Participants will 1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG. 2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG. 3. Protocol-driven CCTA at Week 24 after CABG.
Interventions
DRUGOral isosorbide mononitrate 4+ amlodipine
Oral isosorbide mononitrate 40mg (if unable to tolerate, 20mg) once daily + amlodipine 5mg (if unable to tolerate, 2.5mg) once daily for 24 weeks after CABG
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years old， * Any sex， * Signed informed consent， * Within 3 days after primary isolated CABG using RA graft
Exclusion criteria
1. Allergy to isosorbide mononitrate or amlodipine. 2. Hypotension (systolic BP \<90 mmHg or diastolic BP \<60 mmHg) 3. Acute myocardial infarction or cardiogenic shock 4. Contraindications for CCTA examination (eg., iodine allergy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of RA graft failure at Week 24 | at Week 24 | A protocol-driven CCTA will be used to evaluate the RA graft outcome at Week 24 after CABG. Fitzgibbon Grade B/S/O is definned as Graft Failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to first Major Adverse Cardiovascular Event (MACE) | within 24 weeks | MACE is a composite of all-cause death, myocardial infarction（including peri-operative MI and silent MI), stroke and unplanned revascularization. |
| The proportion of participants with at least once symptomatic hypotension | within 24 weeks | — |
Countries
China
Outcome results
None listed