Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique (HARRA)

Operator Radiation Exposure in Hyper Adduction of Right Radial Artery/Arm vs Left Arm Drag Over Technique.

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Exposure
• Intervention / Treatment: Diagnostic test: Cardiac Catheterization

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.

• Study Type: Observational
• Enrollment (Estimated): 534

Contacts and Locations

• Study Contact: Name: Bilal Malik, MD; Phone Number: 7182837489; Email: bmalik@maimonidesmed.org
• Study Contact Backup: Name: Chirag Agarwal, MD; Phone Number: 7182837489; Email: medicochirag@gmail.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Medical Center
      • Contact: Richard Casazza, RT; Phone Number: 718-283-6879; Email: rcasazza@maimonidesmed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Patients seen at Maimonides Medical Center, who meet the inclusion criteria

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperadducted Right Radial Arm (HARRA); The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to hyperadducted right radial arm will be recorded for primary outcome.	Diagnostic test: Cardiac Catheterization; The cardiac catheterization is an invasive procedure in which right or left radial artery of patient will be accessed to obtain cardiac angiogram. The study participants are both operators and patients by obtaining the amount of radiation they both were exposed in these two different arm techniques. The patient will have to do nothing more than following the existing standard protocols which are followed nationwide. As, the radiation exposure to patients are already measured in the software itself. The operators however would be wearing radiation badges in 4 different anatomic locations to record radiation data for study.
Left Arm Drag over technique; The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected. The radiation dose exposure in patients randomized to Left Arm drag over technique will be recorded for primary outcome.	Diagnostic test: Cardiac Catheterization; The cardiac catheterization is an invasive procedure in which right or left radial artery of patient will be accessed to obtain cardiac angiogram. The study participants are both operators and patients by obtaining the amount of radiation they both were exposed in these two different arm techniques. The patient will have to do nothing more than following the existing standard protocols which are followed nationwide. As, the radiation exposure to patients are already measured in the software itself. The operators however would be wearing radiation badges in 4 different anatomic locations to record radiation data for study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator radiation exposure	The primary operators will wear real time radiation dose monitoring at the left eye, right eye, thorax and abdomen level. At the end of each diagnostic procedure the cumulative radiation dose (measured in µSv) data at each level will be collected	During Cardiac Catheterization
Normalized Dose	The second primary endpoint is Normalized dose, measured by dividing cumulative dose by dose area product (CD/DAP) and entered into query sheet then logged into an Excel spreadsheet.	During Cardiac Catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Area product (DAP)	Dose area product (DAP) is a quantity used in assessing the radiation risk from diagnostic X-ray examinations and interventional procedures. It is defined as the absorbed dose multiplied by the area irradiated, expressed in gray-centimetres squared.	During Cardiac Catheterization
Flouroscopy time	Duration of flouroscopy also known as duration of radiation	During Cardiac Catheterization
mGy	mGy is the unit of absorbed radiation dose	During Cardiac Catheterization
Subclavian tortuosity (Yes/no)	The anatomic complexity in subclavian artery which causes difficulty in performing cardiac catheterization through radial access.	During Cardiac Catheterization

Collaborators and Investigators

• Sponsor: Maimonides Medical Center

Publications and helpful links

General Publications

• Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.
• 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.
• 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.
• 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.
• 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.
• 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.
• De Rosa S, Torella D, Caiazzo G, Giampa S, Indolfi C. Left radial access for percutaneous coronary procedures: from neglected to performer? A meta-analysis of 14 studies including 7,603 procedures. Int J Cardiol. 2014 Jan 15;171(1):66-72. doi: 10.1016/j.ijcard.2013.11.046. Epub 2013 Nov 23.
• Bull JP. Trauma audit. Arch Emerg Med. 1989 Dec;6(4):288-9. doi: 10.1136/emj.6.4.288-b. No abstract available.
• Fu Q, Hu H, Wang D, Chen W, Tan Z, Li Q, Chen B. Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction. Clin Interv Aging. 2015 Jun 24;10:1003-8. doi: 10.2147/CIA.S81568. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: prospective; randomized; cardiac catheterization; radiation dose; operator exposure
• Other Study ID Numbers: #2022-05-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pending decision of research committee and any request generated to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No