DIstal vs Proximal Radial Artery Access for Cath

Study Overview
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Brief Summary
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This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.

Detailed Description
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Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization. Hand function will be assessed by: QuickDASH questionnaire Hand grip test Thumb forefinger pinch test utilizing a pinch gauge Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.

Official Title
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Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention

Conditions
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Coronary Angiography, Coronary Angioplasty

Intervention / Treatment
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* Procedure: Distal radial artery access
* Procedure: Proximal radial artery surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound. Patient should be able to comply with the protocol. Provide written informed consent before study participation Exclusion Criteria: Obligatory femoral or forearm radial access Previous ipsilateral forearm radial artery occlusion. Patient on therapeutic oral anticoagulation. Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands. Enrolment in another study that competes or interferes with this study. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests. Subject with planned complex PCI or procedure necessitating multiple intervention. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. History of stroke with residual deficit that affects hand function. Previous radial artery catheterization within 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, single-center clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal radial artery access<br>Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees. | Procedure: Distal radial artery access<br>* Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.<br>|
| Active Comparator: Proximal radial artery access<br>Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization. | Procedure: Proximal radial artery surgery<br>* Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Disabilities of the Arm Shoulder and Hand (DASH) questionnaire score (0-100) | Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability) | 1 month | 
| Thumb and forefinger pinch strength test | Hand function: Thumb and forefinger pinch strength (kg) | 1 month | 
| Hand grip strength test | Hand grip strength test (kg) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | including occurrence of hematoma, bleeding, radial artery occlusion, and complications of vascular access | 12 month |