Conventional radial artery access
ProcedureHalf of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.
NCT Number: NCT06986889
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.
Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.
Time frame: 24 hours after procedure
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
Time frame: 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.
Time frame: 24 hours before and after procedure, 1 month after procedure
Thumb and forefinger lateral pinch strength (kg)
Time frame: 24 hours before and after procedure, 1 month after procedure
Hand grip strength test (kg)
Time frame: 1 month after procedure
Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure.
Time frame: 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.
Time frame: 24 hours after procedure
Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Feng Li, Ms
CONTACT
Gaojun Cai, MD
CONTACT
Wujin People's Hospital
Other
COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Acronym: CONFINE
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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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