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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Radiation: Radiation dose

• Study Type: Observational
• Enrollment (Actual): 2028

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00168
      • Ospedale Sandro Pertini - ASL RMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Medical operators that performe diagnostic and interventional coronary procedures

Description

Inclusion Criteria:

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion Criteria:

hemodynamic instability, age <18 years

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right transradial; Procedures performed through right transradial approach	Radiation: Radiation dose; Radiation dose adsorbed by operators
Left transradial; Procedures performed through left transradial approach	Radiation: Radiation dose; Radiation dose adsorbed by operators
Femoral; Procedures performed through transfemoral approach	Radiation: Radiation dose; Radiation dose adsorbed by operators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose adsorbed by operators	Radiation Dose adsorbed by operators	Periprocedural

Collaborators and Investigators

• Sponsor: Ospedale Sandro Pertini, Roma

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 26, 2013
• First Submitted That Met QC Criteria: October 26, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Radiation dose, transradial approach, percutaneous coronary interventions, coronary angiography
• Other Study ID Numbers: Pertini3