Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures (RADAR)

London Health Sciences Centre

Status: Completed

Conditions: Radiation Exposure; Patients Undergoing Invasive Cardiac Procedures

Treatments: Device: Novel Lead Based Armboard; Device: Standard Armboard

Study type: Interventional

Funder types: Other

Identifiers

NCT03605030

108913

Details and patient eligibility

About

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

Exclusion criteria

• Inability to provide consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups, including a placebo group

Novel Lead Based Armboard

Active Comparator group

Treatment:

Device: Novel Lead Based Armboard

Standard Armboard

Placebo Comparator group

Treatment:

Device: Standard Armboard