Clinical trial NCT05833516: Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique
Official title: Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Exposure
Keywords: prospective
randomized
radiation dose
operator exposure
cardiac catheterization
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Patients seen at Maimonides Medical Center, who meet the inclusion criteria

Brief summary: Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.

Detailed description: Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.

Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.

This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, \& contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.

Eligibility criteria: Inclusion Criteria:

* All the Cardiac catheterization laboratory physician operators who consent to participate in the study
* Patients of any sex and gender.
* Age \> 18 years old.
* Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings

Exclusion Criteria:

* History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
* Patients undergoing elective PCI (Percutaneous Coronary Intervention)

Primary outcomes:
measure: Operator radiation exposure
timeFrame: During Cardiac Catheterization
measure: Normalized Dose
timeFrame: During Cardiac Catheterization
Secondary outcomes:
measure: Dose Area product (DAP)
timeFrame: During Cardiac Catheterization
measure: Flouroscopy time
timeFrame: During Cardiac Catheterization
measure: mGy
timeFrame: During Cardiac Catheterization
measure: Subclavian tortuosity (Yes/no)
timeFrame: During Cardiac Catheterization
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References:
citation: Sciahbasi A, Romagnoli E, Burzotta F, Trani C, Sarandrea A, Summaria F, Pendenza G, Tommasino A, Patrizi R, Mazzari M, Mongiardo R, Lioy E. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011 Jan;161(1):172-9. doi: 10.1016/j.ahj.2010.10.003.
citation: Dominici M, Diletti R, Milici C, Bock C, Placanica A, D'Alessandro G, Arrivi A, Italiani M, Buono E, Boschetti E. Operator exposure to x-ray in left and right radial access during percutaneous coronary procedures: OPERA randomised study. Heart. 2013 Apr;99(7):480-4. doi: 10.1136/heartjnl-2012-302895. Epub 2013 Jan 23.
citation: Kado H, Patel AM, Suryadevara S, Zenni MM, Box LC, Angiolillo DJ, Bass TA, Guzman LA. Operator radiation exposure and physical discomfort during a right versus left radial approach for coronary interventions: a randomized evaluation. JACC Cardiovasc Interv. 2014 Jul;7(7):810-6. doi: 10.1016/j.jcin.2013.11.026. Epub 2014 Jun 18.
citation: Sciahbasi A, Frigoli E, Sarandrea A, Calabro P, Rubartelli P, Cortese B, Tomassini F, Zavalloni D, Tebaldi M, Calabria P, Rigattieri S, Zingarelli A, Sardella G, Lupi A, Rothenbuhler M, Heg D, Valgimigli M. Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study. Am Heart J. 2018 Feb;196:113-118. doi: 10.1016/j.ahj.2017.10.014. Epub 2017 Oct 28.
citation: Sciahbasi A, Frigoli E, Sarandrea A, Rothenbuhler M, Calabro P, Lupi A, Tomassini F, Cortese B, Rigattieri S, Cerrato E, Zavalloni D, Zingarelli A, Calabria P, Rubartelli P, Sardella G, Tebaldi M, Windecker S, Juni P, Heg D, Valgimigli M. Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RAD-Matrix Trial. J Am Coll Cardiol. 2017 May 23;69(20):2530-2537. doi: 10.1016/j.jacc.2017.03.018. Epub 2017 Mar 18.
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