Prospective randomized non-blinded study to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA).
To determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery, using ultrahigh resolution (55 MHz) ultrasound, following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA) at 90 days post-procedure. Secondary outcome measures will include metrics of procedural success at 24 hours, as well as functional assessment of pain and motor strength of the ipsilateral upper extremity at 90 days post-procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)
Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.
Inova Fairfax Hospital
Falls Church, Virginia, United States
Radial artery intimal medial thickness following dTRA and fTRA
Intimal medial thickness (mm) of the forearm radial artery followed dTRA and fTRA as assessed using ultrahigh resolution 55 MHz ultrasound probe at 90 days post cardiac catheterization.
Time frame: 90 days post-cardiac catheterization.
Radial artery trauma followed dTRA and fTRA
Number of participants with limited access site intimal tears, dissections, thrombosis, occlusions and pseudoaneurysms of the radial artery as assessed using ultrahigh resolution 55 MHz ultrasound at the site of puncture at 90 days post cardiac catheterization
Time frame: 90 days post-cardiac catheterization
Functional assessment of the ipsilateral upper extremity following dTRA and fTRA
Pain and motor strength of the ipsilateral upper extremity using the Borg (0-none to 10-maximal) and Disabilities of the Arm, Shoulders and Hand (DASH) (0-no disability to 100-most severe disability) scales 90 days post-cardiac catheterization.
Time frame: 90 days post-cardiac catheterization
Number of cannulation attempts
Number of cannulation attempts prior to achieving successful vascular access
Time frame: 24 hours post-cardiac catheterization
Radial artery access time
Time (minutes) from initial attempt to successful access of the radial artery.
Time frame: 24 hours post-cardiac catheterization
Access site crossover
Number of patients with failure of radial artery cannulation requiring crossover to alternative radial artery access or transfemoral access
Time frame: 24 hours post-cardiac catheterization
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Total procedural time
Total procedural time (minutes) from time of access to completion of the cardiac catheterization.
Time frame: 24 hours post-cardiac catheterization
Duration of hemostasis
Total duration of hemostasis (minutes) following completion of cardiac catheterization
Time frame: 24 hours post-cardiac catheterization
Incidence of hematomas
Number of patients with EASY Class III or greater hematomas
Time frame: 24 hours post-cardiac catheterization
Percutaneous Coronary Intervention Success
Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention
Time frame: 24 hours post-cardiac catheterization
Coronary dissection
Iatrogenic coronary dissection at the of cardiac catheterization
Time frame: 24 hours post-cardiac catheterization
Myocardial infarction requiring revascularization
Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization.
Time frame: 24 hours post-cardiac catheterization