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

NCT ID: NCT01974453

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2028 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-02-29

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Right transradial

Procedures performed through right transradial approach

Radiation dose

Intervention Type: RADIATION

Radiation dose adsorbed by operators

Left transradial

Procedures performed through left transradial approach

Radiation dose

Intervention Type: RADIATION

Radiation dose adsorbed by operators

Femoral

Procedures performed through transfemoral approach

Radiation dose

Intervention Type: RADIATION

Radiation dose adsorbed by operators

Interventions

Radiation dose

Radiation dose adsorbed by operators

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion Criteria

hemodynamic instability, age <18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Sandro Pertini, Roma

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Sciahbasi, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale Sandro Pertini - ASL RMB

Rome, RM, Italy

Countries

Italy

Other Identifiers

Pertini3

Identifier Type: -

Identifier Source: org_study_id