Coronary Angiography, Distal Radial Artery Access (dTRA), Radial Artery Intimal Medial Thickness, Transradial Access
Conditions
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREdTRA
Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)
PROCEDUREfTRA
Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.
Sponsors
Boston Scientific Corporation
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized non-blinded study evaluating whether distal radial artery access (dTRA) from the anatomic snuffbox is associated with less trauma and adverse remodeling to the forearm radial artery compared to standardard forearm radial access (fTRA).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute 2. Able to provide informed consent. 3. Patients willing to complete a 90day post PCI radial artery ultrasound.
Exclusion criteria
1. Patients with previous cannulation of both the right and left forearm RA's for coronary angiography and/or PCI. In patients with prior cannulation of one RA, the contralateral arm may be used for this study. 2. Patients who are not willing to undergo the necessary follow-up ultrasound examinations. 3. ST elevation myocardial infarction or other emergent PCI 4. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery intimal medial thickness following dTRA and fTRA | 90 days post-cardiac catheterization. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional assessment of the ipsilateral upper extremity following dTRA and fTRA | 90 days post-cardiac catheterization | 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. |
| Number of cannulation attempts | 24 hours post-cardiac catheterization | Number of cannulation attempts prior to achieving successful vascular access |
| Radial artery access time | 24 hours post-cardiac catheterization | Time (minutes) from initial attempt to successful access of the radial artery. |
| Access site crossover | 24 hours post-cardiac catheterization | Number of patients with failure of radial artery cannulation requiring crossover to alternative radial artery access or transfemoral access |
| Total procedural time | 24 hours post-cardiac catheterization | Total procedural time (minutes) from time of access to completion of the cardiac catheterization. |
| Radial artery trauma followed dTRA and fTRA | 90 days post-cardiac catheterization | 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 |
| Incidence of hematomas | 24 hours post-cardiac catheterization | Number of patients with EASY Class III or greater hematomas |
| Percutaneous Coronary Intervention Success | 24 hours post-cardiac catheterization | Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention |
| Coronary dissection | 24 hours post-cardiac catheterization | Iatrogenic coronary dissection at the of cardiac catheterization |
| Myocardial infarction requiring revascularization | 24 hours post-cardiac catheterization | Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization. |
| Duration of hemostasis | 24 hours post-cardiac catheterization | Total duration of hemostasis (minutes) following completion of cardiac catheterization |
Countries
United States
Outcome results
None listed