Coronary Artery Disease, Vascular Access Complication
Conditions
Keywords
L-RECORD, Radial, Femoral, CABG, coronary artery bypass graft
Brief summary
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.
Detailed description
Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.
Interventions
PROCEDURECoronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
Sponsors
Korgialenio-Benakio Red Cross Hospital
University General Hospital of Heraklion
AHEPA University Hospital
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years 2. Written informed consent 3. Clinical indication for coronary angiography in a patient with prior history of CABG 4. Left radial artery has not been used as a graft during CABG
Exclusion criteria
1. Age over 90 years 2. Patient's refusal to participate in the study 3. Hemodynamic instability of the patient 4. Failure to place a sheath at the randomization access site 5. Arteriovenous fistula at the left upper limb 6. Use of right internal mammary artery as a graft during CABG 7. Creatinine clearance \<30 ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Procedure Time | 24 hours | The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | 24 hours | Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography |
| Dose Area Product | 24 hours | Radiation DAP (mGy\*cm2) during the diagnostic coronary angiography |
| Contrast Volume | 24 hours | Contrast volume (ml) used during the diagnostic coronary angiography |
| Total Procedure Time | 24 hours | The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography |
| Major Cardiovascular Events | 24 hours | Death, stroke, acute myocardial infarction |
| Vascular Complications | 24 hours | Vascular access complications |
| Crossover access site | 24 hours | Need for crossover access site, other than this of randomization |
Countries
Greece
Outcome results
None listed