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Completed

NCT Number: NCT04318990

DIstal vs Proximal Radial Artery Access for Cath

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)

    Time frame: 1 year

    Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)

  2. Thumb and Forefinger Pinch Strength Test

    Time frame: 1 year

    Hand function: Thumb and forefinger pinch strength (kg)

  3. Hand Grip Strength Test

    Time frame: 1 month

    Hand grip strength test (kg)

Secondary outcomes

  1. Re-intervention Using the Radial Artery

    Time frame: 1 year

    Patients who required re-intervention using the radial artery up to 1 year following the initial intervention

  2. Radial Artery Occlusion

    Time frame: 1 year

    Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: DIPRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 24, 2020
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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