NCT01839162

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. 1.use of a pelvic shield drape
  2. 2.use of a shield drape on the patient right arm
  3. 3.use of a pelvic shield drape and a shield drape on the patient right arm
  4. 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.
  5. 5.Radiation dose adsorbed by operators according to the radial access (right versus left)
  6. 6.Radiation dose adsorbed by the patients
  7. 7.Radiation dose adsorbed at head level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

April 19, 2013

Last Update Submit

January 27, 2016

Conditions

Myocardial Ischemia

Keywords

Transradial approachshield draperadiationPTCA

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    During procedure

  • Radiation dose adsorbed by the patients

    During procedure

Study Arms (4)

Pelvic drape

EXPERIMENTAL

Pelvic shield drape over the patient

Procedure: Coronary angiographyProcedure: PCIProcedure: Right approachProcedure: Left approach

Arm drape

EXPERIMENTAL

Right radial arm drape over the patient

Procedure: Coronary angiographyProcedure: PCIProcedure: Right approachProcedure: Left approach

Pelvic and arm drape

EXPERIMENTAL

Pelvic and arm drpaes placed over the patient

Procedure: Coronary angiographyProcedure: PCIProcedure: Right approachProcedure: Left approach

No drapes

SHAM COMPARATOR

Standard radioprotection devices

Procedure: Coronary angiographyProcedure: PCIProcedure: Right approachProcedure: Left approach

Interventions

Coronary angiographyPROCEDURE

Diagnostic coronary angiography

Arm drapeNo drapesPelvic and arm drapePelvic drape
PCIPROCEDURE

Percutaneous coronary intervention

Arm drapeNo drapesPelvic and arm drapePelvic drape
Right approachPROCEDURE

Right transradial access

Arm drapeNo drapesPelvic and arm drapePelvic drape
Left approachPROCEDURE

Left transradial access

Arm drapeNo drapesPelvic and arm drapePelvic drape

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica

Rome, Rome, Italy

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

IT(1)