Coronary Artery Disease
Conditions
Keywords
Myocardial Blood Flow, SPECT
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTSPECT 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.
Sponsors
GE Healthcare
Ottawa Heart Institute Research Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * BMI ≤ 40 kg/m2 * Able and willing to comply with the study procedures * Written informed consent * Intermediate to high probability of CAD * Suspected or known CAD on a stable medication regime
Exclusion criteria
* History or risk of severe bradycardia (heart rate \< 50 beats per minute) not related to chronotropic drugs * Known second- or third-degree AV block without pacemaker * Dyspnea (NYHA III/IV), wheezing asthma or COPD * Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or within 45 days after consent (early revascularization) * Percutaneous coronary intervention (PCI) within 30 days prior to screening or within 45 days following consent (early revascularization) * Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox) * Known hypersensitivity to dipyridamole or adenosine * Breastfeeding or pregnancy * Claustrophobia or inability to lie still in a supine position * Unwillingness or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation in MBF Between Core Laboratory and Local Site | The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on Throughput | The average total time the patient was in the camera room during the study protocol was 72.28 minutes. | 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. |
Countries
Belgium, Canada, Germany, Italy, Japan, Singapore
Participant flow
Recruitment details
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%).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | SPECT Imaging With 99mTc-Tetrofosmin | — |
|---|---|---|
| Age, Continuous | 69 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
| Suspected or known coronary artery disease | 35 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPECT Imaging With 99mTc-Tetrofosmin | Correlation in MBF Between Core Laboratory and Local Site | 0.93 correlation coefficient |
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.
Time frame: The average total time the patient was in the camera room during the study protocol was 72.28 minutes.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPECT Imaging With 99mTc-Tetrofosmin | Impact on Throughput | 72.28 minutes | Standard Deviation 9.6 |