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

Not Applicable

Completed

• Conditions: Myocardial Ischemia
• Interventions: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach

• Registration Number: NCT01839162
• Lead Sponsor: Ospedale Sandro Pertini, Roma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic drape	Left approach	Pelvic shield drape over the patient
Arm drape	Left approach	Right radial arm drape over the patient
No drapes	Left approach	Standard radioprotection devices
Pelvic drape	Right approach	Pelvic shield drape over the patient
Pelvic drape	PCI	Pelvic shield drape over the patient
Arm drape	Coronary angiography	Right radial arm drape over the patient
Arm drape	PCI	Right radial arm drape over the patient
Arm drape	Right approach	Right radial arm drape over the patient
No drapes	Right approach	Standard radioprotection devices
Pelvic and arm drape	Coronary angiography	Pelvic and arm drpaes placed over the patient
Pelvic and arm drape	PCI	Pelvic and arm drpaes placed over the patient
No drapes	PCI	Standard radioprotection devices
Pelvic drape	Coronary angiography	Pelvic shield drape over the patient
Pelvic and arm drape	Right approach	Pelvic and arm drpaes placed over the patient
Pelvic and arm drape	Left approach	Pelvic and arm drpaes placed over the patient
No drapes	Coronary angiography	Standard radioprotection devices

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica; 🇮🇹 Rome, Italy