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| ID | Type | Description | Link |
|---|---|---|---|
| R01EB028590 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) provide clinically important information about the severity of suspected coronary artery disease and perfusion defects compared to traditional Energy Integrating Detector CT (EID-CT) and nuclear medicine cardiac stress tests.
This study will focus on demonstrating the benefits of PCD-CT for clinical indications and findings where the improved spatial and temporal resolution, decreased quantum and electronic noise, improved spectral imaging capabilities, and increased iodine signal are expected to benefit the diagnosis and characterization of CAD and myocardial perfusion defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Coronary CTA Cohort | Experimental | Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT. |
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| Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort | Experimental | Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon-counting detector computed tomography (PCD-CT) | Diagnostic Test | Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems |
| Measure | Description | Time Frame |
|---|---|---|
| Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis | Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. | Through completion of CT exam, approximately 1 hour |
| Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest | Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken when the patient was at rest. | Through completion of CT exam, approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score | Coronary Artery Disease-Reporting and Data System (CADRADS) score is a value assigned to each patient based on the patient's highest percent diameter stenosis (PDS) with higher scores indicating worse stenosis. PDS is defined as the diameter of the stenosed (blocked) coronary vessel divided by the diameter of the healthy vessel. A CADRADs score of 0-5 is assigned to the following PDS values, respectively: 0%, 1-24%, 25-49%, 50-70%, 70-99%, and 100%. A CADRAD score was calculated for each patient in both EID-CT and PCD-CT scans based on the respective PDS for the same lesion. The number of patients whose CADRADS decreased in PCD-CT relative to EID-CT (e.g. 2 on PCD-CT, 3 on EID-CT) is reported below. Change in CADRADS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. |
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Inclusion Criteria:
Exclusion Criteria:
Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia McCollough, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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After their clinical scan and before their research scan (intervention), 25 patients withdrew consent, 4 patients failed to meet the inclusion criteria, and 1 patient had an issue with IV placement that prevented scanning resulting in a final cohort of 246 patients.
Patients scheduled for a clinically indicated coronary CT angiogram, stress cardiac MRI, or nuclear cardiovascular stress scan in Mayo Clinic Rochester outpatient practice were invited to participate in this study from August 2022 to February 2026. After their clinical exam, patients were approached by a study coordinator to discuss the research study. If they provided written informed consent, the patient was escorted to their photon-counting detector CT scan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Coronary CTA Cohort | Subjects scheduled for a clinically indicated coronary CT angiogram received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT. |
| FG001 | Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort | Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Coronary CTA Cohort | Subjects scheduled for a clinically indicated coronary CT angiogram received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT. |
| BG001 | Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort |
| 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 | Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis | Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. | To compare PAS, PCD and EID-CT scans are needed so only arm 1 participants were analyzed in this measure. 235 participants were enrolled in arm 1, however 139 participants were analyzed as this outcome measure only pertains to the subset of patients with evaluable, calcified stenosis (i.e., low motion artifact, visible in both scans). Arm 1 was split into and analyzed in 2 groups due to a change in PCD-CT technology during recruitment (multi-energy ultra-high resolution update). | Posted | Median | 95% Confidence Interval |
Adverse events were collected from the time of informed consent through completion of PCD-CT research scan, approximately 1 hour.
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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 | Clinical Coronary CTA Cohort | Subjects scheduled for a clinically indicated coronary CT angiogram received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT (PCD-CT). |
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In arm 1, this study only considers calcified stenosis and makes no claims as to the effect of PCD-CT (versus EID-CT) on non-calcified coronary plaque. Arm 2 recruitment was severely limited because many participants did not want to take a cardiac stress agent. This resulted in a low number of participants in arm 2. Therefore, only descriptive statistics are provided for arm 2.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia McCollough | Mayo Clinic, Rochester | 507-284-6875 | mccollough.cynthia@mayo.edu |
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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 | Feb 1, 2023 | May 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Clinical Stress Test Informed Consent (Arm 2) | Nov 7, 2025 | May 15, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Clinical CT Informed Consent (Arm 1) | Nov 7, 2025 | May 15, 2026 | ICF_001.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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| Through completion of CT exam, approximately 1 hour |
| Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress | Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector CT (PCD-CT) divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken after the patient was administered a pharmacological cardiac stress agent to increase heart rate. | Through completion of CT exam, approximately 1 hour |
Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Percent |
| Through completion of CT exam, approximately 1 hour |
| Stenoses |
| Stenoses |
|
|
|
|
| Primary | Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest | Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken when the patient was at rest. | Perfusion defect analysis requires both nuclear medicine stress tests and photon-counting detector CT. Therefore, only arm 2 of the trial is included in this analysis. | Posted | Number | Percent | Through completion of CT exam, approximately 1 hour |
|
|
|
| Secondary | Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score | Coronary Artery Disease-Reporting and Data System (CADRADS) score is a value assigned to each patient based on the patient's highest percent diameter stenosis (PDS) with higher scores indicating worse stenosis. PDS is defined as the diameter of the stenosed (blocked) coronary vessel divided by the diameter of the healthy vessel. A CADRADs score of 0-5 is assigned to the following PDS values, respectively: 0%, 1-24%, 25-49%, 50-70%, 70-99%, and 100%. A CADRAD score was calculated for each patient in both EID-CT and PCD-CT scans based on the respective PDS for the same lesion. The number of patients whose CADRADS decreased in PCD-CT relative to EID-CT (e.g. 2 on PCD-CT, 3 on EID-CT) is reported below. Change in CADRADS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update. | To compare CADRADS, PCD and EID-CT scans are needed so only arm 1 participants were analyzed in this measure. 235 participants were enrolled in arm 1, however 139 participants were analyzed as this outcome measure only pertains to the subset of patients with evaluable, calcified stenosis (i.e., low motion artifact, visible in both scans). Arm 1 was split into and analyzed in 2 groups due to a change in PCD-CT technology during recruitment (multi-energy ultra-high resolution update). | Posted | Count of Participants | Participants | Through completion of CT exam, approximately 1 hour |
|
|
|
| Secondary | Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress | Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector CT (PCD-CT) divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken after the patient was administered a pharmacological cardiac stress agent to increase heart rate. | Perfusion defect analysis requires both nuclear medicine stress tests and photon-counting detector CT. Therefore, only arm 2 of the trial is included in this analysis. | Posted | Number | Percent | Through completion of CT exam, approximately 1 hour |
|
|
|
| 0 |
| 235 |
| 0 |
| 235 |
| 0 |
| 235 |
| EG001 | Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort | Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test received a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Arm 1b (post-multi-energy scanner update) |
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|