Myocardial IschemiaRADIATIONNCT01839162
RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields
A study testing Coronary angiography, PCI and Right approach in people with Myocardial Ischemia, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Coronary angiography, PCI and Right approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
Who cannot join
- Previous coronary artery by-pass
- Acute ST elevation myocardial infarction
- Hemodynamic instability or cardiogenic shock
- Ischemic Allen test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)
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.
Read more
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:
- use of a pelvic shield drape
- use of a shield drape on the patient right arm
- use of a pelvic shield drape and a shield drape on the patient right arm
- 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:
- Radiation dose adsorbed by operators according to the radial access (right versus left)
- Radiation dose adsorbed by the patients
- Radiation dose adsorbed at head level.
- Conditions
- Myocardial Ischemia
- Being tested
- Coronary angiography, PCI, Right approach, Left approach
- Keywords
- Transradial approach, shield drape, radiation, PTCA
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
Diagnostic coronary angiography
PCIProcedure or surgery
Percutaneous coronary intervention
Right approachProcedure or surgery
Right transradial access
Left approachProcedure or surgery
Left transradial access
| Study group | Role | What they receive |
|---|---|---|
| Pelvic drape | Experimental | Pelvic shield drape over the patient Receives: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach |
| Arm drape | Experimental | Right radial arm drape over the patient Receives: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach |
| Pelvic and arm drape | Experimental | Pelvic and arm drpaes placed over the patient Receives: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach |
| No drapes | Sham comparator | Standard radioprotection devices Receives: Procedure: Coronary angiography; Procedure: PCI; Procedure: Right approach; Procedure: Left approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During procedure
Secondary outcomes (2)
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)
Measured: During procedure
Radiation dose adsorbed by the patients
Radiation dose adsorbed by the patients
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Sandro Pertini, Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839162
- Sponsor's protocol ID
- ASLRMB-Pertini1
- Acronym
- RADIATION
- Status last verified
- Jan 2016
- First submitted
- 19 Apr 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields (The RADIATION Study)
- ClinicalTrials.gov ID
- NCT01839162
- Acronym / sponsor ID
- RADIATION / ASLRMB-Pertini1
- Conditions
- Myocardial Ischemia
- Keywords
- Transradial approach, shield drape, radiation, PTCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- use of a pelvic shield drape
- use of a shield drape on the patient right arm
- use of a pelvic shield drape and a shield drape on the patient right arm
- 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:
- Radiation dose adsorbed by operators according to the radial access (right versus left)
- Radiation dose adsorbed by the patients
- Radiation dose adsorbed at head level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pelvic drape | Experimental | Procedure: Coronary angiography, Procedure: PCI, Procedure: Right approach, Procedure: Left approachPelvic shield drape over the patient |
| Arm drape | Experimental | Procedure: Coronary angiography, Procedure: PCI, Procedure: Right approach, Procedure: Left approachRight radial arm drape over the patient |
| Pelvic and arm drape | Experimental | Procedure: Coronary angiography, Procedure: PCI, Procedure: Right approach, Procedure: Left approachPelvic and arm drpaes placed over the patient |
| No drapes | Sham comparator | Procedure: Coronary angiography, Procedure: PCI, Procedure: Right approach, Procedure: Left approachStandard radioprotection devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
Key exclusion criteria (4 listed)
- Previous coronary artery by-pass
- Acute ST elevation myocardial infarction
- Hemodynamic instability or cardiogenic shock
- Ischemic Allen test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiographyDiagnostic coronary angiography | Procedure or surgery | Arm drape, No drapes, Pelvic and arm drape, Pelvic drape |
| PCIPercutaneous coronary intervention | Procedure or surgery | Arm drape, No drapes, Pelvic and arm drape, Pelvic drape |
| Right approachRight transradial access | Procedure or surgery | Arm drape, No drapes, Pelvic and arm drape, Pelvic drape |
| Left approachLeft transradial access | Procedure or surgery | Arm drape, No drapes, Pelvic and arm drape, Pelvic drape |
Primary outcome
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
2 secondary outcomes
Radiation dose adsorbed by operators according to the radial access (right versus left)
Time frame: During procedure
Radiation dose adsorbed by the patients
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary angiography, PCI and Right approach in people with Myocardial Ischemia, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose adsorbed by operators (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.