Viewing Study NCT01974453



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Study NCT ID: NCT01974453
Status: COMPLETED
Last Update Posted: 2017-04-06
First Post: 2013-10-26

Brief Title: RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach RADIANT Observational Study
Sponsor: Ospedale Sandro Pertini Roma
Organization: Ospedale Sandro Pertini Roma

Study Overview

Official Title: RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach RADIANT Observational Study
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RADIANT
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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None