COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 640
- Primary Endpoint
- Hand Numbness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Distal radial artery access group
Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access.
Intervention: Distal radial artery access (Procedure)
Conventional radial artery access group
Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access.
Intervention: Conventional radial artery access (Procedure)
Outcomes
Primary Outcomes
Hand Numbness
Time Frame: 24 hours after procedure
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
Secondary Outcomes
- Thumb and Index Finger Pinch Test(24 hours before and after procedure, 1 month after procedure)
- Hand Paresthesia(24 hours and 1 month after procedure)
- Hand Clumsiness(24 hours and 1 month after procedure)
- Nerve Injury(24 hours and 1 month after procedure)
- Hand Grip Test(24 hours before and after procedure, 1 month after procedure)
- Late-term Hand Numbness(1 month after procedure)
- Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)(24 hours before procedure and 1 month after procedure)
- Visual Analogue Scale (VAS) Scale (0-10)(24 hours after procedure)