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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01839162
Acronym
RADIATION
Enrollment
452
Registered
2013-04-24
Start date
2013-04-30
Completion date
2015-12-31
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

Transradial approach, shield drape, radiation, PTCA

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: 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.

Interventions

PROCEDURECoronary angiography

Diagnostic coronary angiography

PROCEDUREPCI

Percutaneous coronary intervention

Right transradial access

PROCEDURELeft approach

Left transradial access

Sponsors

Ospedale Sandro Pertini, Roma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiation dose adsorbed by operatorsDuring procedurePrimary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters

Secondary

MeasureTime frameDescription
Radiation dose adsorbed by operators according to the radial access (right versus left)During procedureRadiation dose adsorbed by operators according to the radial access (right versus left)
Radiation dose adsorbed by the patientsDuring procedureRadiation dose adsorbed by the patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026