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

This study is currently recruiting participants.
Verified October 2013 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 26, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention
Myocardial Ischemia
Procedure: Coronary angiography
Procedure: PCI
Procedure: Right approach
Procedure: Left approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)

Resource links provided by NLM:


Further study details as provided by Ospedale Sandro Pertini, Roma:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839162

Contacts
Contact: Alessandro Sciahbasi, MD +390641433871 alessandro.sciahbasi@fastwebnet.it

Locations
Italy
Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica Recruiting
Rome, Italy
Contact: Alessandro Sciahbasi, MD    +390641433871    alessandro.sciahbasi@fastwebnet.it   
Contact: Stefano Rigattieri, MD    +390641433871    stefanorigattieri@yahoo.it   
Principal Investigator: Alessandro Sciahbasi, MD         
Sub-Investigator: Stefano Rigattieri, MD         
Sponsors and Collaborators
Ospedale Sandro Pertini, Roma
  More Information

No publications provided

Responsible Party: Alessandro Sciahbasi, MD, Interventional Cardiologist, Ospedale Sandro Pertini, Roma
ClinicalTrials.gov Identifier: NCT01839162     History of Changes
Other Study ID Numbers: ASLRMB-Pertini1
Study First Received: April 19, 2013
Last Updated: October 26, 2013
Health Authority: Italy: AIFA (Agenzia Italiana del Farmaco)

Keywords provided by Ospedale Sandro Pertini, Roma:
Transradial approach
shield drape
radiation
PTCA

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014