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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI), who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study. Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin. This is an observational study; patients will be managed according to the standard clinical care of the local site. Where available, a CT scan will also be acquired for attenuation and/or scatter correction. Studies may be one day (rest/stress or stress/rest) or two day (rest and stress on separate days) All studies will be analyzed locally but the raw data will also be anonymized and forwarded to the core facility for reprocessing. Central processing will allow comparison between sites and the repeat processing will provide an estimate of inter-operator variability in the measurements. The core lab will also compare the relative perfusion from immediate and delayed imaging for image quality and diagnostic accuracy (visual and quantitative).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT Imaging with 99mTc-Tetrofosmin | Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT Imaging with 99mTc-Tetrofosmin Research Imaging | Diagnostic Test | This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation in MBF Between Core Laboratory and Local Site | MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF. | The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on Throughput | Additional acquisition time for the MBF acquisition. For each patient study, the time during which the patient was in the camera room for each imaging session was recorded along with the start times for each scan. From this data, the increase in time for MBF protocol compared with the time for a standard myocardial perfusion imaging protocol was determined. | The average total time the patient was in the camera room during the study protocol was 72.28 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the local site, have known or suspected CAD and are deemed to clincally require MBF measurements.
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| Name | Affiliation | Role |
|---|---|---|
| Terrence Ruddy, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire ziekenhuizen Leuven | Leuven | Belgium | ||||
| London Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37800325 | Derived | Wells RG, Bengel FM, Camoni L, Cerudelli E, Cuddy-Walsh SG, Diekmann J, Han L, Kadoya Y, Kawaguchi N, Keng YJF, Miyagawa M, Ratner H, Teng XF, Ruddy TD. Multicenter Evaluation of the Feasibility of Clinical Implementation of SPECT Myocardial Blood Flow Measurement: Intersite Variability and Imaging Time. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015009. doi: 10.1161/CIRCIMAGING.122.015009. Epub 2023 Oct 6. |
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Patients were excluded from the study prior to performing the research imaging if they had PCI or CABG after the consent process. Patients who were found to be pregnant or breastfeeding post consent were also excluded.
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%).
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| ID | Title | Description |
|---|---|---|
| FG000 | SPECT Imaging With 99mTc-Tetrofosmin | Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin SPECT Imaging with 99mTc-Tetrofosmin Research Imaging: This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPECT Imaging With 99mTc-Tetrofosmin | Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin SPECT Imaging with 99mTc-Tetrofosmin Research Imaging: This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation in MBF Between Core Laboratory and Local Site | MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF. | Myocardial perfusion images were acquired from patients undergoing clinically indicated single photon emission computed tomography myocardial perfusion imaging. Patients were included if they were at least 18 years of age, had a body mass index of less than 40kg/m2, and were of intermediate to high pretest probability of coronary artery disease on a stable medication regimen. All 35 patients scanned were included in the study. | Posted | Number | 95% Confidence Interval | correlation coefficient | The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes. |
12 months, over the course of the whole study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPECT Imaging With 99mTc-Tetrofosmin | Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin SPECT Imaging with 99mTc-Tetrofosmin Research Imaging: This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terrence Ruddy | University of Ottawa Heart Institute | 613-696-7267 | truddy@ottawaheart.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2021 | Aug 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| London |
| Ontario |
| Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Nuclear Medicine, Università & Spedali Civili, Brescia, Italy | Brescia | Italy |
| Ehime University Hospital | Tōon | Japan |
| National Heart Center Singapore | Singapore | 169609 | Singapore |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Suspected or known coronary artery disease | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | SPECT Imaging With 99mTc-Tetrofosmin | Participants were injected with 42 +/-14 MBq of 99mTc-Tetrofosmin 20 minutes before imaging. dynamic tracer injections were delivered using a syringe pump over a duration of 30 seconds, followed by a 60 second flush. The injection flow rate was 14 mL/min for (7mL tracer, 14 mL flush). List mode data were acquired starting immediately before tracer injection and for a duration of 11 minutes. Relative perfusion images were obtained between 30 and 60 minutes after tracer injection for clinical evaluation. Each site acquired 35 patient data sets which were analyzed as part of the trial. All raw study data was transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter-site processing consistency. |
|
|
| Secondary | Impact on Throughput | Additional acquisition time for the MBF acquisition. For each patient study, the time during which the patient was in the camera room for each imaging session was recorded along with the start times for each scan. From this data, the increase in time for MBF protocol compared with the time for a standard myocardial perfusion imaging protocol was determined. | Myocardial perfusion images were acquired from patients undergoing clinically indicated single photon emission computed tomography myocardial perfusion imaging. Patients were included if they were at least 18 years of age, had a body mass index of less than 40kg/m2, and were of intermediate to high pretest probability of coronary artery disease on a stable medication regimen. All 35 patients scanned were included in the study. | Posted | Mean | Standard Deviation | minutes | The average total time the patient was in the camera room during the study protocol was 72.28 minutes. |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |