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

Myocardial Ischemia Clinical Trial

— RADIATION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839162
• Other study ID #: ASLRMB-Pertini1
• Status: Completed
• Phase: N/A
• First received: April 19, 2013
• Last updated: January 27, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Ospedale Sandro Pertini, Roma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA (Agenzia Italiana del Farmaco)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary angiography
Diagnostic coronary angiography
• PCI
Percutaneous coronary intervention
• Right approach
Right transradial access
• Left approach
Left transradial access

Locations

Country	Name	City	State
Italy	Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Sandro Pertini, Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose adsorbed by operators	Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters	During procedure	No
Secondary	Radiation dose adsorbed by operators according to the radial access (right versus left)	Radiation dose adsorbed by operators according to the radial access (right versus left)	During procedure	No
Secondary	Radiation dose adsorbed by the patients	Radiation dose adsorbed by the patients	During procedure	No