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

NCT01839162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2016-01-28

No results posted yet for this study

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:

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.

Conditions

  • Myocardial Ischemia

Interventions

PROCEDURE

Coronary angiography

Diagnostic coronary angiography

PROCEDURE

PCI

Percutaneous coronary intervention

PROCEDURE

Right approach

Right transradial access

PROCEDURE

Left approach

Left transradial access

Sponsors & Collaborators

  • Ospedale Sandro Pertini, Roma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01839162 on ClinicalTrials.gov