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

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. 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:

1. Radiation dose adsorbed by operators according to the radial access (right versus left)
2. Radiation dose adsorbed by the patients
3. Radiation dose adsorbed at head level.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Ospedale Sandro Pertini, Roma

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: radiation; PTCA; Transradial approach; shield drape
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: ASLRMB-Pertini1