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

Completed

• Conditions: Radiation Exposure
• Interventions: Diagnostic Test: Cardiac Catheterization

• Registration Number: NCT05833516
• Lead Sponsor: Maimonides Medical Center

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.

Study Timeline

• Study Start: 2022-11-10
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-27
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left Arm Drag over technique	Cardiac Catheterization	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.
Hyperadducted Right Radial Arm (HARRA)	Cardiac Catheterization	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.

Primary Outcome Measures

Name	Time	Method
Normalized Dose	During Cardiac Catheterization	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.
Operator radiation exposure	During Cardiac Catheterization	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

Secondary Outcome Measures

Name	Time	Method
mGy	During Cardiac Catheterization	mGy is the unit of absorbed radiation dose
Flouroscopy time	During Cardiac Catheterization	Duration of flouroscopy also known as duration of radiation
Dose Area product (DAP)	During Cardiac Catheterization	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.
Subclavian tortuosity (Yes/no)	During Cardiac Catheterization	The anatomic complexity in subclavian artery which causes difficulty in performing cardiac catheterization through radial access.

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States