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

NCT01974453 | Completed

• 1 other identifier: Pertini3
• Study Type: observational
• Target: 2,028
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Exposure

Keywords

Radiation dose, transradial approach, percutaneous coronary interventions, coronary angiography

Outcome Measures

Primary Outcomes (1)

• Radiation Dose adsorbed by operators

  Radiation Dose adsorbed by operators

  Periprocedural

Study Arms (3)

Right transradial

Procedures performed through right transradial approach

Radiation: Radiation dose

Left transradial

Procedures performed through left transradial approach

Radiation: Radiation dose

Femoral

Procedures performed through transfemoral approach

Radiation: Radiation dose

Interventions

Radiation dose RADIATION

Radiation dose adsorbed by operators

Femoral; Left transradial; Right transradial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medical operators that performe diagnostic and interventional coronary procedures

You may qualify if:

• All patients who underwent to percutaneous coronary diagnostic or interventional procedures

You may not qualify if:

• hemodynamic instability, age \<18 years

Sponsors & Collaborators

• Ospedale Sandro Pertini, Roma: lead

Study Sites (1)

Ospedale Sandro Pertini - ASL RMB

Rome, RM, 00168, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 26, 2013
• First Posted: November 1, 2013
• Study Start: August 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

IT (1)