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Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.
This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial access | Active Comparator |
| |
| Femoral access | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial access versus femoral access for coronary angiography and intervention | Procedure | Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of contrast used | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | 24 hours | |
| Fluoroscopy time | 24 hours | |
| Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanouil s Brilakis, MD, PhD | North Texas Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24139930 | Result | Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16. |
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| 24 hours |
| Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices | 24 hours |
| Performance of ascending aortic angiography to identify patent bypass grafts | 24 hours |
| Number of catheters and wires used | 24 hours |
| Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding) | 24 hours |
| Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) | 24 hours |
| Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure | 24 hours |
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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