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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04318990
Other study ID # 019-504 DIPRA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Distal radial artery access
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.
Proximal radial artery surgery
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.

Locations

Country Name City State
United States Baylor Scott & White The Heart Hospital - Plano Plano Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 year
Primary Thumb and Forefinger Pinch Strength Test Hand function: Thumb and forefinger pinch strength (kg) 1 year
Primary Hand Grip Strength Test Hand grip strength test (kg) 1 month
Secondary Re-intervention Using the Radial Artery Patients who required re-intervention using the radial artery up to 1 year following the initial intervention 1 year
Secondary Radial Artery Occlusion Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access 1 year
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