Exposure to Ionizing RadiationPhase 3XRay ReductionNCT01334931
Use of Large Field of View During Image Acquisition for Coronary Angiography
A Phase 3 study testing Large field of view arm and Medium field of view in people with Exposure to Ionizing Radiation and Occupational Exposure to Radiation, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Exposure to Ionizing Radiation, Occupational Exposure to Radiation, Radiation Injury
- What is being tested?
- Large field of view arm and Medium field of view
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Mar 2012
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of diagnostic coronary angiography for suspected coronary artery disease
- Sign written consent form
Who cannot join
- Therapeutics procedures
- Urgency/emergency procedures
- Previous CABG
- Severe valvular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure
Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.
- Being tested
- Large field of view arm, Medium field of view
- Keywords
- Exposure to Ionizing Radiation, Occupational Exposure to Radiation
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large field of view armRadiation
Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)
Medium field of viewRadiation
Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)
| Study group | Role | What they receive |
|---|---|---|
| Large field of view | Experimental | Patients will have coronary angiography performed with large field of view lens Receives: Radiation: Large field of view arm |
| Medium field of view | Active comparator | Patients will have coronary angiography performed with medium field of view lens Receives: Radiation: Medium field of view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's radiation exposure
Patient's radiation exposure will be measured in mGy at the end of procedure
Measured: 24 hours
Secondary outcomes (1)
Physician and nurse radiation exposure
Physician and nurse radiation exposure will be measured in microSv at the end of procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Ionizing RadiationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano de Oliveira Cardoso, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Cristiano O Cardoso, MD, MSc, Study chair, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334931
- Sponsor's protocol ID
- UP 4454/10
- Acronym
- XRay Reduction
- Status last verified
- May 2012
- First submitted
- 5 Apr 2011
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure
- ClinicalTrials.gov ID
- NCT01334931
- Acronym / sponsor ID
- XRay Reduction / UP 4454/10
- Keywords
- Exposure to Ionizing Radiation, Occupational Exposure to Radiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Apr 2011 (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.
Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large field of view | Experimental | Radiation: Large field of view armPatients will have coronary angiography performed with large field of view lens |
| Medium field of view | Active comparator | Radiation: Medium field of viewPatients will have coronary angiography performed with medium field of view lens |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication of diagnostic coronary angiography for suspected coronary artery disease
- Sign written consent form
Key exclusion criteria (4 listed)
- Therapeutics procedures
- Urgency/emergency procedures
- Previous CABG
- Severe valvular disease
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 |
|---|---|---|
| Large field of view armPatients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm) | Radiation | Large field of view |
| Medium field of viewPatients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm) | Radiation | Medium field of view |
Primary outcome
Patient's radiation exposure
Time frame: 24 hours
Patient's radiation exposure will be measured in mGy at the end of procedure
1 secondary outcome
Physician and nurse radiation exposure
Time frame: 24 hours
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 9 May 2012.
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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.
Cristiano O Cardoso, MD, MSc study chair
Instituto de Cardiologia do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Large field of view arm and Medium field of view in people with Exposure to Ionizing Radiation and Occupational Exposure to Radiation, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 2 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 9 May 2012. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient's radiation exposure (time frame: 24 hours). 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 9 May 2012.