RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (RADIATION)
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Coronary angiography
PCI
Right approach
Left approach
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Ischemia focused on measuring Transradial approach, shield drape, radiation, PTCA
Eligibility Criteria
Inclusion Criteria:
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
Exclusion Criteria:
- Previous coronary artery by-pass
- Acute ST elevation myocardial infarction
- Hemodynamic instability or cardiogenic shock
- Ischemic Allen test.
Sites / Locations
- Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Pelvic drape
Arm drape
Pelvic and arm drape
No drapes
Arm Description
Pelvic shield drape over the patient
Right radial arm drape over the patient
Pelvic and arm drpaes placed over the patient
Standard radioprotection devices
Outcomes
Primary Outcome Measures
Radiation dose adsorbed by operators
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters
Secondary Outcome Measures
Radiation dose adsorbed by operators according to the radial access (right versus left)
Radiation dose adsorbed by operators according to the radial access (right versus left)
Radiation dose adsorbed by the patients
Radiation dose adsorbed by the patients
Full Information
NCT ID
NCT01839162
First Posted
April 19, 2013
Last Updated
January 27, 2016
Sponsor
Ospedale Sandro Pertini, Roma
1. Study Identification
Unique Protocol Identification Number
NCT01839162
Brief Title
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields
Acronym
RADIATION
Official Title
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Sandro Pertini, Roma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
use of a pelvic shield drape
use of a shield drape on the patient right arm
use of a pelvic shield drape and a shield drape on the patient right arm
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. Since December 2013 the operators are equipped with a further dosimeter at head level.
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:
Radiation dose adsorbed by operators according to the radial access (right versus left)
Radiation dose adsorbed by the patients
Radiation dose adsorbed at head level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Transradial approach, shield drape, radiation, PTCA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic drape
Arm Type
Experimental
Arm Description
Pelvic shield drape over the patient
Arm Title
Arm drape
Arm Type
Experimental
Arm Description
Right radial arm drape over the patient
Arm Title
Pelvic and arm drape
Arm Type
Experimental
Arm Description
Pelvic and arm drpaes placed over the patient
Arm Title
No drapes
Arm Type
Sham Comparator
Arm Description
Standard radioprotection devices
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography
Intervention Description
Diagnostic coronary angiography
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
Right approach
Intervention Description
Right transradial access
Intervention Type
Procedure
Intervention Name(s)
Left approach
Intervention Description
Left transradial access
Primary Outcome Measure Information:
Title
Radiation dose adsorbed by operators
Description
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Radiation dose adsorbed by operators according to the radial access (right versus left)
Description
Radiation dose adsorbed by operators according to the radial access (right versus left)
Time Frame
During procedure
Title
Radiation dose adsorbed by the patients
Description
Radiation dose adsorbed by the patients
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
Exclusion Criteria:
Previous coronary artery by-pass
Acute ST elevation myocardial infarction
Hemodynamic instability or cardiogenic shock
Ischemic Allen test.
Facility Information:
Facility Name
Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica
City
Rome
Country
Italy
12. IPD Sharing Statement
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RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields
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