Clinical trial NCT06986889: Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access
Official title: COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Distal Raidal Artery
Hand Functions
Keywords: Coronary arterial disease
Distal radial artery
Conventional radial artery
Hand dysfunction
Lead sponsor: Wujin People's Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-center clinical trial
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hand Numbness
timeFrame: 24 hours after procedure
Secondary outcomes:
measure: Nerve Injury
timeFrame: 24 hours and 1 month after procedure
measure: Thumb and Index Finger Pinch Test
timeFrame: 24 hours before and after procedure, 1 month after procedure
measure: Hand Grip Test
timeFrame: 24 hours before and after procedure, 1 month after procedure
measure: Late-term Hand Numbness
timeFrame: 1 month after procedure
measure: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)
timeFrame: 24 hours before procedure and 1 month after procedure
measure: Visual Analogue Scale (VAS) Scale (0-10)
timeFrame: 24 hours after procedure
measure: Hand Paresthesia
timeFrame: 24 hours and 1 month after procedure
measure: Hand Clumsiness
timeFrame: 24 hours and 1 month after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular department, Changzhou Wujin People's Hospital
name: Gaojun Cai, MD
role: STUDY_CHAIR
References:
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