Cardiovascular DiseasesPhase 1NCT00817115
Evaluation of Exposure Reduction Using Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) in Cardiac Interventions
A Phase 1 study testing Region-of-Interest Imaging (X-ray Fovea Imaging) in people with Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during cardiac interventional procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Region-of-Interest Imaging (X-ray Fovea Imaging)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 1
- 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
- The subject is greater than 18 years of age.
- The subject is currently planned for conventional cardiac interventional procedures (i.e. catheterization, percutaneous coronary intervention (PCI), electrophysiology (EP) ablations and procedures) as specified by his/her physician.
- The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
Who cannot join
- The subject is pregnant or trying to become pregnant.
- The subject requires urgent/emergent cardiac catheterization, PCI, and/or EP procedures as per treating physician.
- The subject has been previously included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial to Determine Non-inferiority of Exposure Dose Reduction and Diagnostic Performance of Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) Compared to Standard Fluoroscopy in Patients Undergoing Cardiac Interventional Procedures
The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during cardiac interventional procedures. It is hypothesized that systematic application of x-ray attenuation will significantly reduce the radiation exposure of the interventional procedure while maintaining image quality, thereby decreasing risk to the patient.
Read the detailed description
X-ray catheterization is used to guide minimally invasive procedures including percutaneous coronary interventions (PCIs), involving diffuse and multiple vessel disease and total chronic occlusion as well as electrophysiology (EP) procedures. While the medical benefit to patients outweighs the procedural risk, long fluoroscopy times associated with complex interventions have resulted in acute radiation injuries to patients. Radiation induced cancers have also become a concern in younger patient populations. With the increased number, diversity and complexity of the interventions performed, there has been a growing interest in reducing the long-term exposure risk to medical personnel (interventionists).
Conventional methods to reduce in radiation exposure, however, impact and often degrade diagnostic image quality. Catheterization procedures focus on a small portion of the anatomy forming the central region of the image with the periphery providing contextual information. Thus, decreasing the image quality in periphery can provide an overall exposure reduction to patients and interventionists without impacting on diagnosis. This can be achieved by introducing a pre-patient region-of-interest (ROI) attenuator that collimates the primary x-ray beam, reducing exposure to peripheral regions and decreasing integral radiation to the patient and scatter radiation to the interventionist.
The goal of this study is to investigate the exposure dose reduction provided by ROI imaging to patients and interventionists undergoing catheterization and to examine the feasibility of using the ROI attenuator in routine clinical practice for future integration into commercial x-ray imaging systems. The aim is to obtain exposure dose data and cardiac angiography images from subjects undergoing routine interventional procedures performed with and without ROI attenuation (experimental and control groups, respectively). For the experimental group, the interventionists performing the procedure will determine the appropriate application of the ROI attenuator and the duration of its use on specific patient lesions. An internal pilot study will be initially conducted on approximately 30 patients (15 per group) to obtain estimates on patient and operator dose reduction and variability. The on-going clinical trial will then be performed on an additional 40 patients (where the final protocol procedures and recruitment will be refined based on results from the pilot study).
- Conditions
- Cardiovascular Diseases
- Being tested
- Region-of-Interest Imaging (X-ray Fovea Imaging)
- Keywords
- Region-of-Interest Imaging, X-ray Fovea Imaging, Cardiovascular Diseases, Radiation Dosage, Radiographic Image Enhancement, Radiography, Interventional
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Region-of-Interest Imaging (X-ray Fovea Imaging)Device
Use of an experimental fluoroscopy system fitted with a region-of-interest attenuator (fovea) to evaluate or treat lesions during cardiac interventional procedures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Subjects undergoing routine cardiac catheterization or interventional procedures using the standard fluoroscopy system. |
| 2 | Experimental | Subjects undergoing routine cardiac catheterization or interventional procedures using the region-of-interest fluoroscopy (x-ray fovea imaging) system. Receives: Device: Region-of-Interest Imaging (X-ray Fovea Imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray exposure area product, primary and scatter radiation to patient and interventionist and procedure and irradiation time for interventions performed without and with region-of-interest imaging (control and experimental arms, respectively).
Measured: The outcome measure will be recorded per patient procedure. A comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).
Secondary outcomes (1)
Quality and diagnostic benefit of images obtained without and with the region-of-interest imaging.
Measured: Retrospective expert comparison of images from patient procedures (between control and experimental arms) will occur within 1 to 3 months after the completion of the pilot study and the full study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Investigators
- Alexander J Dick, MD, Principal investigator, Sunnybrook Health Sciences CentreNormand Robert, PhD, Study director, Sunnybrook Health Sciences CentreJohn A Rowlands, PhD, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817115
- Sponsor's protocol ID
- 005-2008
- Status last verified
- Jan 2009
- First submitted
- 14 Nov 2008
- Last updated
- 7 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Determine Non-inferiority of Exposure Dose Reduction and Diagnostic Performance of Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) Compared to Standard Fluoroscopy in Patients Undergoing Cardiac Interventional Procedures
- ClinicalTrials.gov ID
- NCT00817115
- Acronym / sponsor ID
- 005-2008
- Conditions
- Cardiovascular Diseases
- Keywords
- Region-of-Interest Imaging, X-ray Fovea Imaging, Cardiovascular Diseases, Radiation Dosage, Radiographic Image Enhancement, Radiography, Interventional
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (estimated)
- First posted
- 6 Jan 2009 (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.
The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during cardiac interventional procedures. It is hypothesized that systematic application of x-ray attenuation will significantly reduce the radiation exposure of the interventional procedure while maintaining image quality, thereby decreasing risk to the patient.
Detailed description
X-ray catheterization is used to guide minimally invasive procedures including percutaneous coronary interventions (PCIs), involving diffuse and multiple vessel disease and total chronic occlusion as well as electrophysiology (EP) procedures. While the medical benefit to patients outweighs the procedural risk, long fluoroscopy times associated with complex interventions have resulted in acute radiation injuries to patients. Radiation induced cancers have also become a concern in younger patient populations. With the increased number, diversity and complexity of the interventions performed, there has been a growing interest in reducing the long-term exposure risk to medical personnel (interventionists).
Conventional methods to reduce in radiation exposure, however, impact and often degrade diagnostic image quality. Catheterization procedures focus on a small portion of the anatomy forming the central region of the image with the periphery providing contextual information. Thus, decreasing the image quality in periphery can provide an overall exposure reduction to patients and interventionists without impacting on diagnosis. This can be achieved by introducing a pre-patient region-of-interest (ROI) attenuator that collimates the primary x-ray beam, reducing exposure to peripheral regions and decreasing integral radiation to the patient and scatter radiation to the interventionist.
The goal of this study is to investigate the exposure dose reduction provided by ROI imaging to patients and interventionists undergoing catheterization and to examine the feasibility of using the ROI attenuator in routine clinical practice for future integration into commercial x-ray imaging systems. The aim is to obtain exposure dose data and cardiac angiography images from subjects undergoing routine interventional procedures performed with and without ROI attenuation (experimental and control groups, respectively). For the experimental group, the interventionists performing the procedure will determine the appropriate application of the ROI attenuator and the duration of its use on specific patient lesions. An internal pilot study will be initially conducted on approximately 30 patients (15 per group) to obtain estimates on patient and operator dose reduction and variability. The on-going clinical trial will then be performed on an additional 40 patients (where the final protocol procedures and recruitment will be refined based on results from the pilot study).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Subjects undergoing routine cardiac catheterization or interventional procedures using the standard fluoroscopy system. |
| 2 | Experimental | Device: Region-of-Interest Imaging (X-ray Fovea Imaging)Subjects undergoing routine cardiac catheterization or interventional procedures using the region-of-interest fluoroscopy (x-ray fovea imaging) system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is greater than 18 years of age.
- The subject is currently planned for conventional cardiac interventional procedures (i.e. catheterization, percutaneous coronary intervention (PCI), electrophysiology (EP) ablations and procedures) as specified by his/her physician.
- The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
Key exclusion criteria (3 listed)
- The subject is pregnant or trying to become pregnant.
- The subject requires urgent/emergent cardiac catheterization, PCI, and/or EP procedures as per treating physician.
- The subject has been previously included in the study.
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 |
|---|---|---|
| Region-of-Interest Imaging (X-ray Fovea Imaging)Use of an experimental fluoroscopy system fitted with a region-of-interest attenuator (fovea) to evaluate or treat lesions during cardiac interventional procedures. | Device | 2 |
Primary outcome
X-ray exposure area product, primary and scatter radiation to patient and interventionist and procedure and irradiation time for interventions performed without and with region-of-interest imaging (control and experimental arms, respectively).
Time frame: The outcome measure will be recorded per patient procedure. A comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).
1 secondary outcome
Quality and diagnostic benefit of images obtained without and with the region-of-interest imaging.
Time frame: Retrospective expert comparison of images from patient procedures (between control and experimental arms) will occur within 1 to 3 months after the completion of the pilot study and the full study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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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.
Alexander J Dick, MD principal investigator
Sunnybrook Health Sciences Centre
Normand Robert, PhD study director
Sunnybrook Health Sciences Centre
John A Rowlands, PhD study chair
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Region-of-Interest Imaging (X-ray Fovea Imaging) in people with Cardiovascular Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2009. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
X-ray exposure area product, primary and scatter radiation to patient and interventionist and procedure and irradiation time for interventions performed without and with region-of-interest imaging (control and experimental arms, respectively). (time frame: The outcome measure will be recorded per patient procedure. A comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).). 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 7 Aug 2009.