RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)

Completed

• Conditions: Radiation Exposure
• Interventions: Radiation: Radiation dose

• Registration Number: NCT01974453
• Lead Sponsor: Ospedale Sandro Pertini, Roma

Brief Summary

Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. In particular the most important are the position taken by the operator, the use of dedicated X-ray shield and the duration of the procedure. However other factors (as operator height or the angulation of the radiation tube) might have some important effects but are often under-evaluated .

Aim of our observational study is to evaluate the most important determinants of the radiation dose adsorbed by operators during different coronary procedures (diagnostic coronary angiography or percutaneous coronary interventions) and through different vascular accesses (right or left transradial approach or transfemoral approach).

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this observational study.

Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax level outside the lead apron and at head level to evaluate the radiation dose at crystalline. Effective doses delivered to patients will be expressed as dose area product (DAP) and measured in Gycm2.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2028

Inclusion Criteria

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion Criteria

hemodynamic instability, age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Femoral	Radiation dose	Procedures performed through transfemoral approach
Right transradial	Radiation dose	Procedures performed through right transradial approach
Left transradial	Radiation dose	Procedures performed through left transradial approach

Primary Outcome Measures

Name	Time	Method
Radiation Dose adsorbed by operators	Periprocedural	Radiation Dose adsorbed by operators

Trial Locations

Locations (1)

Ospedale Sandro Pertini - ASL RMB; 🇮🇹 Rome, RM, Italy