DIstal vs Proximal Radial Artery Access for Cath (DIPRA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Angioplasty; Coronary Angiography
• Intervention / Treatment: Procedure: Distal radial artery access; Procedure: Proximal radial artery surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Scott & White The Heart Hospital - Plano
      • Contact: Preethi Ravindranathan, MS; Phone Number: 469-814-4721; Email: preethi.ravindranathan@bswhealth.org
      • Contact: Meletath, MBBS
      • Principal Investigator: Karim Al-Azizi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 month
Thumb and forefinger pinch strength test	Hand function: Thumb and forefinger pinch strength (kg)	1 month
Hand grip strength test	Hand grip strength test (kg)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications	including occurrence of hematoma, bleeding, radial artery occlusion, and complications of vascular access	12 month

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2020
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 019-504 DIPRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No