DIstal vs Proximal Radial Artery Access for Cath

NCT ID: NCT04318990

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2022-12-31

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.

Conditions

Coronary Angiography; Coronary Angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Distal radial artery access

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.

Group Type: EXPERIMENTAL

Distal radial artery access

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Proximal radial artery surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37889176 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34637140 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

019-504 DIPRA

Identifier Type: -

Identifier Source: org_study_id