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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839162
First Posted: April 24, 2013
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
  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. 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)

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

Primary Outcome Measures:
  • Radiation dose adsorbed by operators [ Time Frame: During procedure ]
    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 ]
    Radiation dose adsorbed by operators according to the radial access (right versus left)

  • Radiation dose adsorbed by the patients [ Time Frame: During procedure ]
    Radiation dose adsorbed by the patients


Enrollment: 452
Study Start Date: April 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839162


Locations
Italy
Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica
Rome, Italy
Sponsors and Collaborators
Ospedale Sandro Pertini, Roma
  More Information

Responsible Party: Alessandro Sciahbasi, MD, Interventional Cardiologist, Ospedale Sandro Pertini, Roma
ClinicalTrials.gov Identifier: NCT01839162     History of Changes
Other Study ID Numbers: ASLRMB-Pertini1
First Submitted: April 19, 2013
First Posted: April 24, 2013
Last Update Posted: January 28, 2016
Last Verified: January 2016

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

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