Clinical trial NCT04318990: DIstal vs Proximal Radial Artery Access for Cath
Official title: Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angiography
Coronary Angioplasty
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-center clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
3. Patient should be able to comply with the protocol.
4. Provide written informed consent before study participation

Exclusion Criteria:

1. Obligatory femoral or forearm radial access
2. Previous ipsilateral forearm radial artery occlusion.
3. Patient on therapeutic oral anticoagulation.
4. Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
5. Enrolment in another study that competes or interferes with this study.
6. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
7. Subject with planned complex PCI or procedure necessitating multiple intervention.
8. 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.
9. History of stroke with residual deficit that affects hand function.
10. Previous radial artery catheterization within 1 year.

Primary outcomes:
measure: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
timeFrame: 1 year
measure: Thumb and Forefinger Pinch Strength Test
timeFrame: 1 year
measure: Hand Grip Strength Test
timeFrame: 1 month
Secondary outcomes:
measure: Re-intervention Using the Radial Artery
timeFrame: 1 year
measure: Radial Artery Occlusion
timeFrame: 1 year
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
Study officials:
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.