RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (RADIATION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ospedale Sandro Pertini, Roma
Sponsor:
Information provided by (Responsible Party):
Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
ClinicalTrials.gov Identifier:
NCT01839162
First received: April 19, 2013
Last updated: October 17, 2014
Last verified: October 2014

April 19, 2013
October 17, 2014
April 2013
April 2015   (final data collection date for primary outcome measure)
Radiation dose adsorbed by operators [ Time Frame: During procedure ] [ Designated as safety issue: No ]
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters
Same as current
Complete list of historical versions of study NCT01839162 on ClinicalTrials.gov Archive Site
  • Radiation dose adsorbed by operators according to the radial access (right versus left) [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    Radiation dose adsorbed by operators according to the radial access (right versus left)
  • Radiation dose adsorbed by the patients [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    Radiation dose adsorbed by the patients
Same as current
Not Provided
Not Provided
 
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)

During percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. No studies evaluated the effect of both adjunctive shields placed in the same patient.

Aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none.

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. Eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups:

  1. use of a pelvic shield drape
  2. use of a shield drape on the patient right arm
  3. use of a pelvic shield drape and a shield drape on the patient right arm
  4. Any adjunctive shield drape (only standard radio-protection) For each group a further internal randomization will be performed in order to compare the right or left radial transradial approach.

Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron.

Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters.

Secondary end-point are:

  1. Radiation dose adsorbed by operators according to the radial access (right versus left)
  2. Radiation dose adsorbed by the patients
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myocardial Ischemia
  • Procedure: Coronary angiography
    Diagnostic coronary angiography
  • Procedure: PCI
    Percutaneous coronary intervention
  • Procedure: Right approach
    Right transradial access
  • Procedure: Left approach
    Left transradial access
  • Experimental: Pelvic drape
    Pelvic shield drape over the patient
    Interventions:
    • Procedure: Coronary angiography
    • Procedure: PCI
    • Procedure: Right approach
    • Procedure: Left approach
  • Experimental: Arm drape
    Right radial arm drape over the patient
    Interventions:
    • Procedure: Coronary angiography
    • Procedure: PCI
    • Procedure: Right approach
    • Procedure: Left approach
  • Experimental: Pelvic and arm drape
    Pelvic and arm drpaes placed over the patient
    Interventions:
    • Procedure: Coronary angiography
    • Procedure: PCI
    • Procedure: Right approach
    • Procedure: Left approach
  • Sham Comparator: No drapes
    Standard radioprotection devices
    Interventions:
    • Procedure: Coronary angiography
    • Procedure: PCI
    • Procedure: Right approach
    • Procedure: Left approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study

Exclusion Criteria:

  1. Previous coronary artery by-pass
  2. Acute ST elevation myocardial infarction
  3. Hemodynamic instability or cardiogenic shock
  4. Ischemic Allen test.
Both
18 Years and older
No
Contact: Alessandro Sciahbasi, MD +390641433871 alessandro.sciahbasi@fastwebnet.it
Italy
 
NCT01839162
ASLRMB-Pertini1
No
Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
Ospedale Sandro Pertini, Roma
Not Provided
Not Provided
Ospedale Sandro Pertini, Roma
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP