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

Study Overview
=================
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.

Official Title
-----------------
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: Coronary angiography
* Procedure: PCI
* Procedure: Right approach
* Procedure: Left approach


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic drape<br>Pelvic shield drape over the patient | Procedure: Coronary angiography<br>* Diagnostic coronary angiography<br>Procedure: PCI<br>* Percutaneous coronary intervention<br>Procedure: Right approach<br>* Right transradial access<br>Procedure: Left approach<br>* Left transradial access<br>|
| Experimental: Arm drape<br>Right radial arm drape over the patient | Procedure: Coronary angiography<br>* Diagnostic coronary angiography<br>Procedure: PCI<br>* Percutaneous coronary intervention<br>Procedure: Right approach<br>* Right transradial access<br>Procedure: Left approach<br>* Left transradial access<br>|
| Experimental: Pelvic and arm drape<br>Pelvic and arm drpaes placed over the patient | Procedure: Coronary angiography<br>* Diagnostic coronary angiography<br>Procedure: PCI<br>* Percutaneous coronary intervention<br>Procedure: Right approach<br>* Right transradial access<br>Procedure: Left approach<br>* Left transradial access<br>|
| Sham Comparator: No drapes<br>Standard radioprotection devices | Procedure: Coronary angiography<br>* Diagnostic coronary angiography<br>Procedure: PCI<br>* Percutaneous coronary intervention<br>Procedure: Right approach<br>* Right transradial access<br>Procedure: Left approach<br>* Left transradial access<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | During procedure | 
| Radiation dose adsorbed by the patients | Radiation dose adsorbed by the patients | During procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transradial approach, shield drape, radiation, PTCA