Coronary Arterial Disease (CAD), Distal Raidal Artery, Hand Functions
Conditions
Keywords
Coronary arterial disease, Distal radial artery, Conventional radial artery, Hand dysfunction
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.
Interventions
PROCEDUREConventional 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.
PROCEDUREDistal 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.
Sponsors
Wujin People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, randomized, single-center clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Numbness | 24 hours after procedure | Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thumb and Index Finger Pinch Test | 24 hours before and after procedure, 1 month after procedure | Thumb and forefinger lateral pinch strength (kg) |
| Hand Grip Test | 24 hours before and after procedure, 1 month after procedure | Hand grip strength test (kg) |
| Late-term Hand Numbness | 1 month after procedure | Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure. |
| Nerve Injury | 24 hours and 1 month after procedure | Number of participants with the nerve injury is detected using high-frequent ultrasound or electromyography at 24 hours after procedure, and patients with nerve injury at 1 month follow-up will be recorded. |
| Visual Analogue Scale (VAS) Scale (0-10) | 24 hours after procedure | Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity. |
| Hand Paresthesia | 24 hours and 1 month after procedure | Number of participants with the hand paresthesia is assessed using monofilament test and/or two-point discrimination test at 24 hours after procedure, and patients with hand paresthesia at 1 month follow-up will be recorded. |
| Hand Clumsiness | 24 hours and 1 month after procedure | Number of participants with the hand clumsiness at 24 hours after procedure, and patients with hand clumsiness at 1 month follow-up will be recorded. |
| Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100) | 24 hours before procedure and 1 month after procedure | Upper extremity dysfunction questionnaire. Scores range from 0 to 100, with higher scores indicating greater dysfunction. |
Contacts
Primary ContactFeng Li, Ms
Backup ContactGaojun Cai, MD
Outcome results
None listed