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NCT Number: NCT06986889

Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional radial artery access

Procedure

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

Distal radial artery access

Procedure

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

Primary outcomes

  1. 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

  1. Nerve Injury

    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.

  2. Thumb and Index Finger Pinch Test

    Time frame: 24 hours before and after procedure, 1 month after procedure

    Thumb and forefinger lateral pinch strength (kg)

  3. Hand Grip Test

    Time frame: 24 hours before and after procedure, 1 month after procedure

    Hand grip strength test (kg)

  4. Late-term Hand Numbness

    Time frame: 1 month after procedure

    Number of participants with the hand numbness is evaluated through clinical consultations at 1 month after procedure.

  5. Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)

    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.

  6. Visual Analogue Scale (VAS) Scale (0-10)

    Time frame: 24 hours after procedure

    Pain assessment. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

  7. Hand Paresthesia

    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.

  8. Hand Clumsiness

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Li, Ms

CONTACT

[email protected]

+86-0519-85579192

Gaojun Cai, MD

CONTACT

[email protected]

+86-0519-85579193

Sponsors and collaborators

Lead sponsor

Wujin People's Hospital

Other

Registry information

Official study title

COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)

Acronym: CONFINE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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