DIstal vs Proximal Radial Artery Access for Cath

NCT04318990 | Completed Results

• 1 other identifier: 019-504 DIPRA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Angiography; Coronary Angioplasty

Outcome Measures

Primary Outcomes (3)

• 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

• Thumb and Forefinger Pinch Strength Test

  Hand function: Thumb and forefinger pinch strength (kg)

  1 year

• Hand Grip Strength Test

  Hand grip strength test (kg)

  1 month

Secondary Outcomes (2)

• Re-intervention Using the Radial Artery

  1 year

• Radial Artery Occlusion

  1 year

Study Arms (2)

Distal radial artery access

EXPERIMENTAL

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

Proximal radial artery access

ACTIVE COMPARATOR

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

Interventions

Distal radial artery access PROCEDURE

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.

Distal radial artery access

Proximal radial artery surgery PROCEDURE

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 access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Related Publications (2)

• Al-Azizi K, Moubarak G, Dib C, Sayfo S, Szerlip M, Thomas S, McCracken J, Smith A, Kelavkar U, Hale S, Van Zyl J, McCoy SL, Lanfear AT, Banwait JK, Ravindranathan P, Chionh K, DiMaio JM, Mack MJ, Potluri S. Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 30-Day Outcomes of the DIPRA Study. J Am Heart Assoc. 2023 Nov 7;12(21):e030774. doi: 10.1161/JAHA.123.030774. Epub 2023 Oct 27.

  PMID: 37889176 DERIVED

• 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.

  PMID: 34637140 DERIVED

Results Point of Contact

• Title: Sarah Hale
• Organization: Baylor Scott and White Resarch Institute

sarah.hale@bswhealth.org

469-814-4845

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, single-center clinical trial

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: March 6, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2020-03

Locations

US (1)