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

Maimonides Medical Center

Status: Completed

Conditions: Radiation Exposure

Treatments: Diagnostic Test: Cardiac Catheterization

Study type: Observational

Funder types: Other

Identifiers

NCT05833516

#2022-05-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 534 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

534 participants in 2 patient groups

Hyperadducted Right Radial Arm (HARRA)

Description:

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.

Treatment:

Diagnostic Test: Cardiac Catheterization

Left Arm Drag over technique

Description:

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.

Treatment:

Diagnostic Test: Cardiac Catheterization