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Completed

NCT Number: NCT01839162

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study

Exclusion criteria

  • Previous coronary artery by-pass
  • Acute ST elevation myocardial infarction
  • Hemodynamic instability or cardiogenic shock
  • Ischemic Allen test.

Treatment and study plan

Coronary Angiography

Procedure

Diagnostic coronary angiography

PCI

Procedure

Percutaneous coronary intervention

Right approach

Procedure

Right transradial access

Left approach

Procedure

Left transradial access

Primary outcomes

  1. Radiation dose adsorbed by operators

    Time frame: 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 outcomes

  1. Radiation dose adsorbed by operators according to the radial access (right versus left)

    Time frame: During procedure

    Radiation dose adsorbed by operators according to the radial access (right versus left)

  2. Radiation dose adsorbed by the patients

    Time frame: During procedure

    Radiation dose adsorbed by the patients

Sponsors and collaborators

Lead sponsor

Ospedale Sandro Pertini, Roma

Other

Registry information

Official study title

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

Acronym: RADIATION

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2013
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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