Coronary Artery DiseaseSFSO-MPINCT02576886
Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results
A study testing Gamma Camera and Prone Imaging in people with Coronary Artery Disease, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Participants are being asked to participate in this research study because the participant's doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography) scan to look at the blood flow in the participants heart. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Gamma Camera and Prone Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any patient referred for a clinically indicated rest/stress myocardial perfusion imaging test
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences - Hamilton General Site
Hamilton, Ontario, L8L 2X2
About this study
Official title: Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results in Patients Undergoing Testing in a Tertiary Care Facility
Participants are being asked to participate in this research study because the participant's doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography) scan to look at the blood flow in the participants heart.
Myocardial perfusion imaging is a proven test that looks at the blood flow to the participant's heart after the injection of a radioactive tracer. The standard test requires two injections of the radioactive tracer and takes images of the participant's heart at rest and after a stress test. It has been proposed that in some cases, patients could have images done only after the stress portion of the test and, if normal, the rest images would not need to be done. In this case, only one injection of the radioactive tracer would be needed. It has further been proposed that adding another stress image made with the participant lying on their stomach, will increase the confidence of the reporting doctor in reporting stress images.
The purpose of this study is to find out if the extra information added from the image with the participant on their stomach helps the doctor when reporting the test results.
Read the detailed description
Successfully implementing a SFSO-MPI protocol requires a validated pre-screening tool and a proven imaging protocol that aids the physician in reporting the study with confidence. The investigator's previous study, entitled "The feasibility of Stress-First/Stress-Only Myocardial Perfusion Imaging to reduce patient radiation exposure in a selected subset of patients undergoing testing in a tertiary care facility (SFSO-MPI)", was designed to validate a pre-screening tool developed by Duvall et al. In the investigator's population the tool demonstrated sensitivity and specificity (95% CI) of 0.79 (0.74-0.83) and 0.55 (0.48-0.62) (unpublished data). The sensitivity was lower than previous published. However the investigators noted that a greater proportion of participants were classified as abnormal (55% vs 31 and 36% in the two cohorts described by Duvall et al) and a high number of patients (15%) were reported as having equivocal stress images. These factors may have affected the sensitivity of the pre-screening tool. A greater proportion of the investigator's participants would then have required a rest study for proper interpretation of the test. Additional imaging increases the patients' radiation exposure and time requirement for the study and affects the proper allocation of department resources.
The department routinely images patients in only the supine position. The implementation of routine combined supine/prone imaging is expected to decrease image artifacts which may reduce the number of studies reported as equivocal. If combined supine/prone imaging is successful in changing the interpretation of a significant proportion of equivocal stress studies to normal, then the need for rest imaging will be obviated in a larger group of patients, resulting in reduced radiation dose to patients and medical staff, better laboratory efficiency due to faster throughput, reduced time commitment for patients and lower radiopharmaceutical cost. This change to practice will also further aid meeting the American Society of Nuclear Cardiology (ASNC) goal of no more than 9mSv patient exposure in 50% of studies.
- Conditions
- Coronary Artery Disease
- Being tested
- Gamma Camera, Prone Imaging
- Keywords
- supine, prone, myocardial perfusion imaging, radiation exposure, pre-screening tool
- Medical subject headings
- Coronary Artery Disease, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma CameraDevice
Also called General Electric Discovery 530c
All images acquired with the General Electric Discovery 530c
Prone ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supine/Prone Imaging | Experimental | The patient will be imaged in the standard supine position and then an additional image will be acquired of the patient in the prone position. Receives: Device: Gamma Camera; Procedure: Prone Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the screening tool for each imaging protocol will be evaluated in terms of sensitivity and specificity to predict an unsuccessful SFSO study.
The performance of the screening tool with supine-only and combined supine-prone imaging will be compared with a McNemar Chi-squared test for each of Group 1 and Group 2 to determine if the combined imaging protocol reduces equivocal results.
Measured: day of test
Secondary outcomes (1)
Negative predictive value (i.e. the likelihood of successfully predicting a normal MPI based on the screening tool and a normal stress test) will be calculated for each of Group 1 and Group 2 with supine, and supine/prone imaging.
The results for each group will be compared using a paired t-test, while results across groups will be compared using an unpaired t-test.
Measured: day of test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startSep 2015
- 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 Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Gulenchyn, MD,FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576886
- Sponsor's protocol ID
- 01-15-CARD-001
- Acronym
- SFSO-MPI
- Status last verified
- Jan 2016
- First submitted
- 13 Oct 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Supine/Prone Acquisitions in Stress-First/Stress-Only Myocardial Perfusion Imaging to Reduce Equivocal Results in Patients Undergoing Testing in a Tertiary Care Facility
- ClinicalTrials.gov ID
- NCT02576886
- Acronym / sponsor ID
- SFSO-MPI / 01-15-CARD-001
- Conditions
- Coronary Artery Disease
- Keywords
- supine, prone, myocardial perfusion imaging, radiation exposure, pre-screening tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Oct 2015 (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.
Participants are being asked to participate in this research study because the participant's doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography) scan to look at the blood flow in the participants heart.
Myocardial perfusion imaging is a proven test that looks at the blood flow to the participant's heart after the injection of a radioactive tracer. The standard test requires two injections of the radioactive tracer and takes images of the participant's heart at rest and after a stress test. It has been proposed that in some cases, patients could have images done only after the stress portion of the test and, if normal, the rest images would not need to be done. In this case, only one injection of the radioactive tracer would be needed. It has further been proposed that adding another stress image made with the participant lying on their stomach, will increase the confidence of the reporting doctor in reporting stress images.
The purpose of this study is to find out if the extra information added from the image with the participant on their stomach helps the doctor when reporting the test results.
Detailed description
Successfully implementing a SFSO-MPI protocol requires a validated pre-screening tool and a proven imaging protocol that aids the physician in reporting the study with confidence. The investigator's previous study, entitled "The feasibility of Stress-First/Stress-Only Myocardial Perfusion Imaging to reduce patient radiation exposure in a selected subset of patients undergoing testing in a tertiary care facility (SFSO-MPI)", was designed to validate a pre-screening tool developed by Duvall et al. In the investigator's population the tool demonstrated sensitivity and specificity (95% CI) of 0.79 (0.74-0.83) and 0.55 (0.48-0.62) (unpublished data). The sensitivity was lower than previous published. However the investigators noted that a greater proportion of participants were classified as abnormal (55% vs 31 and 36% in the two cohorts described by Duvall et al) and a high number of patients (15%) were reported as having equivocal stress images. These factors may have affected the sensitivity of the pre-screening tool. A greater proportion of the investigator's participants would then have required a rest study for proper interpretation of the test. Additional imaging increases the patients' radiation exposure and time requirement for the study and affects the proper allocation of department resources.
The department routinely images patients in only the supine position. The implementation of routine combined supine/prone imaging is expected to decrease image artifacts which may reduce the number of studies reported as equivocal. If combined supine/prone imaging is successful in changing the interpretation of a significant proportion of equivocal stress studies to normal, then the need for rest imaging will be obviated in a larger group of patients, resulting in reduced radiation dose to patients and medical staff, better laboratory efficiency due to faster throughput, reduced time commitment for patients and lower radiopharmaceutical cost. This change to practice will also further aid meeting the American Society of Nuclear Cardiology (ASNC) goal of no more than 9mSv patient exposure in 50% of studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supine/Prone Imaging | Experimental | Device: Gamma Camera, Procedure: Prone ImagingThe patient will be imaged in the standard supine position and then an additional image will be acquired of the patient in the prone position. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient referred for a clinically indicated rest/stress myocardial perfusion imaging test
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Gamma CameraAlso: General Electric Discovery 530cAll images acquired with the General Electric Discovery 530c | Device | Supine/Prone Imaging |
| Prone Imaging | Procedure or surgery | Supine/Prone Imaging |
Primary outcome
Performance of the screening tool for each imaging protocol will be evaluated in terms of sensitivity and specificity to predict an unsuccessful SFSO study.
Time frame: day of test
The performance of the screening tool with supine-only and combined supine-prone imaging will be compared with a McNemar Chi-squared test for each of Group 1 and Group 2 to determine if the combined imaging protocol reduces equivocal results.
1 secondary outcome
Negative predictive value (i.e. the likelihood of successfully predicting a normal MPI based on the screening tool and a normal stress test) will be calculated for each of Group 1 and Group 2 with supine, and supine/prone imaging.
Time frame: day of test
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 15 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.
Karen Gulenchyn, MD,FRCPC principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Camera and Prone Imaging in people with Coronary Artery Disease, run by Hamilton Health Sciences Corporation 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 1 inclusion and 1 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 15 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 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.
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?
Performance of the screening tool for each imaging protocol will be evaluated in terms of sensitivity and specificity to predict an unsuccessful SFSO study. (time frame: day of test). 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 15 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.