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

Ospedale Sandro Pertini, Roma

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Procedure: Coronary angiography; Procedure: PCI; Procedure: Left approach; Procedure: Right approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01839162

ASLRMB-Pertini1

Details and patient eligibility

About

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.

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 4 patient groups

Pelvic drape

Experimental group

Description:

Pelvic shield drape over the patient

Treatment:

Procedure: Left approach

Procedure: PCI

Procedure: Right approach

Procedure: Coronary angiography

Arm drape

Experimental group

Description:

Right radial arm drape over the patient

Treatment:

Procedure: Left approach

Procedure: PCI

Procedure: Right approach

Procedure: Coronary angiography

Pelvic and arm drape

Experimental group

Description:

Pelvic and arm drpaes placed over the patient

Treatment:

Procedure: Left approach

Procedure: PCI

Procedure: Right approach

Procedure: Coronary angiography

No drapes

Sham Comparator group

Description:

Standard radioprotection devices

Treatment:

Procedure: Left approach

Procedure: PCI

Procedure: Right approach

Procedure: Coronary angiography