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New study with a similar endpoint/protocol was developed (see NCT03103061).
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To assess the ability of a novel 3rd generation dual-source CT system to demonstrate myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute chest pain.
The investigators will assess the latest generation of CT scanner for heart disease detection. On this new machine the investigators will analyse the ability of the machine to show the delivery of blood to the heart muscle. Results will be compared with the results from the gold standard test for myocardial perfusion imaging, which is an imaging test that shows the blood supply to the heart muscle. Further analyses will record the amount of radiation, which is how the CT machine acquires images, and compare the amount of radiation necessary to produce images to previous CT systems. With this new CT system there should be reductions in the amount of radiation dose compared to previous systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myocardial Stress CT Perfusion | Experimental | Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatom Force CT Scanner | Device | Dynamic CT perfusion of the heart |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Dynamic Perfusion CT | The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| CTMP/SPECT MPI Disagreement | Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis | 1 Day |
| Radiation Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Myocardial Stress CT Perfusion | Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.
| 1 Day |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Myocardial Stress CT Perfusion | Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| Height | Mean | Full Range | inches |
| |||||||||||||||||
| Weight | Mean | Full Range | lbs |
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| 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 | Diagnostic Accuracy of Dynamic Perfusion CT | The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test. | The planned statistical analyses were not performed. | Posted | 1 Day |
|
| |||||||||||||||||||
| Secondary | CTMP/SPECT MPI Disagreement | Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis | The planned statistical analyses were not performed. | Posted | 1 Day |
|
| |||||||||||||||||||
| Secondary | Radiation Dose | Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT. | The planned statistical analyses were not performed. | Posted | 1 Day |
|
|
6 months
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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 | Myocardial Stress CT Perfusion | Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. Somatom Force CT Scanner: Dynamic CT perfusion of the heart | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | Systematic Assessment | ED visit for chest pain radiating to the shoulder and abdomen |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Jacobs - Program Assistant | Medical University of South Carolina | 843-876-4922 | jacobsbr@musc.edu |
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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