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

Inclusion Criteria1

  • We will include all patients who undergo coronary procedures with radial access at Austin Health or John Hunter Hospital who consent to OCT-guided assessment of their radial arteries, between approval of the study and the end of the study period, excluding those with needs for emergent coronary procedures where the time delay required to obtain pre-procedure OCT imaging may cause significant harm (i.e. patients with ST-elevation myocardial infarction or those with non-ST elevation myocardial infarction and ongoing chest pain/haemodynamic instability). Patients with advanced chronic kidney disease [CKD] (CKD-IV and above, eGFR =29) will be excluded.

Exclusion Criteria1

  • Patients with advanced chronic kidney disease [CKD] (CKD-IV and above, eGFR =29) will be excluded (as the additional contrast load required to correctly perform the OCT runs risks contrast nephropathy). Patients with ST-elevation myocardial infarction or those with non-ST elevation myocardial infarction and ongoing chest pain/haemodynamic instability will be excluded as the brief delay (approximately ten minutes) required to perform the pre-procedure OCT runs would represent unacceptable risk.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12626000075381


Related Trials