DIstal vs Proximal Radial Artery Access for Cath

Coronary Angiography Clinical Trial

— DIPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318990
• Other study ID #: 019-504 DIPRA
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Coronary Angiography
• Coronary Angioplasty

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