Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-05-20

Brief Summary

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Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access

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Detailed Description

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Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure.

The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month.

Hand sensory and motor dysfunction will be assessed by:

* Consultation and physical examination
* Hand grip test
* Hand pinch test (lateral pinch)
* Monofilament sensory test
* Quick DASH questionnaire
* High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.

Conditions

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Coronary Arterial Disease (CAD) Distal Raidal Artery Hand Functions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, single-center clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Distal radial artery access group

Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access.

Group Type EXPERIMENTAL

Distal radial artery access

Intervention Type PROCEDURE

Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.

Conventional radial artery access group

Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access.

Group Type ACTIVE_COMPARATOR

Conventional radial artery access

Intervention Type PROCEDURE

Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.

Interventions

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Conventional radial artery access

Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.

Intervention Type PROCEDURE

Distal radial artery access

Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Indications for coronary diagnosis and intervention
* Distal and conventional radial artery pulsation are palpable
* Patient should be able to comply with the protocol

Exclusion Criteria

* Age \< 18 years or ≥ 90 years
* Height ≥ 185 cm
* Acute STEMI
* Haemodynamic instability
* Contraindications to puncture at the puncture site (such as infection, scarring or indwelling needles)
* Enrollment in another study that competes or interferes with this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No