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

Sponsor

Ospedale Sandro Pertini, Roma (Other)

Overall Status

Completed

CT.gov ID

NCT01839162

Collaborator

(none)

452

Enrollment

Location

Arms

Duration (Months)

14.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia	Procedure: Coronary angiography Procedure: PCI Procedure: Right approach Procedure: Left approach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

452 participants

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)

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Radiation dose adsorbed by operators [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) [During procedure]
Radiation dose adsorbed by operators according to the radial access (right versus left)
Radiation dose adsorbed by the patients [During procedure]
Radiation dose adsorbed by the patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica	Rome		Italy

Sponsors and Collaborators

Ospedale Sandro Pertini, Roma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessandro Sciahbasi, MD, Interventional Cardiologist, Ospedale Sandro Pertini, Roma

ClinicalTrials.gov Identifier:

NCT01839162

Other Study ID Numbers:

ASLRMB-Pertini1

First Posted:

Apr 24, 2013

Last Update Posted:

Jan 28, 2016

Last Verified:

Jan 1, 2016

Keywords provided by Alessandro Sciahbasi, MD, Interventional Cardiologist, Ospedale Sandro Pertini, Roma

Additional relevant MeSH terms:

Myocardial Ischemia

Ischemia

Study Results

No Results Posted as of Jan 28, 2016