RecruitingACTRN12626000075381

Optical Coherence Tomography Assessment of Radial Artery Injuries Caused by Trans-Radial Access

Optical Coherence Tomography Assessment of Radial Artery Injuries Caused by Trans-Radial Access in Patients undergoing Coronary Procedures


Sponsor

Austin Health

Enrollment

50 participants

Start Date

Mar 19, 2025

Study Type

Observational

Conditions

Summary

This is an observational study, where we will use a catheter pre- and post-coronary procedures to look for damage to the radial artery caused by trans-radial access. The primary hypothesis is that the radial artery sheath protect the radial artery from spasm and radial artery injuries, and looking at the distribution of injuries along the artery before and after the procedure will allow us to investigate this and guide strategies to protect patients (potential surgical candidates) at higher risk of radial artery injury. We will also study demographic data to help identify these patients that are more susceptible to injury.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Many heart procedures are now performed through the radial artery at the wrist — a technique called trans-radial access — rather than through larger vessels elsewhere in the body. This approach is generally safer and more comfortable for patients, but the artery can sometimes be damaged during the procedure. This study is using a small imaging catheter inside the artery — called optical coherence tomography (OCT) — to take detailed pictures of the radial artery before and after the procedure, looking for signs of injury. The goal is to understand where injuries occur along the artery and whether the sheath used during the procedure helps protect it. Researchers will also look at patient characteristics to see who may be at higher risk of injury — information that could guide how procedures are planned for people who might need their radial artery for future surgeries, such as bypass surgery. You may be eligible if you are having a planned coronary procedure via radial access at Austin Health or John Hunter Hospital and are willing to have the OCT assessment done at the same time. People with advanced kidney disease or those arriving with a heart attack and urgent need for intervention will not be eligible, as the slight delay required for imaging would pose unacceptable risk.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

For patients undergoing elective trans-radial catheterisation for coronary procedures, we will attempt to study injuries and changes to the radial artery caused by radial access by imaging the radial

For patients undergoing elective trans-radial catheterisation for coronary procedures, we will attempt to study injuries and changes to the radial artery caused by radial access by imaging the radial artery with optical coherence tomography (OCT) at the beginning and end of the coronary procedure. For patients, this means providing consent to collect demographic and biochemical data, and consenting to an additional OCT catheter being utilised at the beginning and end of the coronary case (adding approximately 10-15 minutes to their total procedure time) in order to assess the radial arteries. There will be a very small increase in radiation exposure to position the catheter in the radial artery using fluoroscopy guidance. If patients are planned for repeat/staged procedures, they can consent to having repeat OCT assessment (but this is, of course, not obligatory).


Locations(1)

NSW,VIC, Australia

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