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OpenTrials
Completed

NCT Number: NCT01974453

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Sandro Pertini - ASL RMB

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion criteria

hemodynamic instability, age <18 years

Treatment and study plan

Radiation dose

Radiation

Radiation dose adsorbed by operators

Primary outcomes

  1. Radiation Dose adsorbed by operators

    Time frame: Periprocedural

    Radiation Dose adsorbed by operators

Sponsors and collaborators

Lead sponsor

Ospedale Sandro Pertini, Roma

Other

Registry information

Acronym: RADIANT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2013
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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