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The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose CT, Ultra-low dose CT | Other | Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra low dose non-contrast enhanced CT | Device | Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT | CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT. Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis. Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement. | 1 days |
| Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT | For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Treyer, PhD | University of Zurich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, University Hospital Zurich | Zurich | 8091 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose CT, Ultra-low Dose CT | Standard dose and ultra-low dose non-contrast enhanced CT Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol Ultra-low dose non-contrast enhanced CT: Additional scan as part of the trial |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dose CT, Ultra-low Dose CT | Standard dose non-contrast enhanced CT Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT | CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT. Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis. Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement. | 2/105 participants were not analyzed due to corrupt datasets. | Posted | Median | Inter-Quartile Range | Agatston score | 1 days |
|
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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 | Standard Dose CT | Standard dose non-contrast enhanced CT Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronny Buechel | University Hospital Zurich | 0041442551059 | ronny.buechel@usz.ch |
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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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| Standard dose non-contrast enhanced CT | Device | Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol |
|
| Participants |
|
| 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 |
|
| OG000 | Standard Dose CT | Standard dose non-contrast enhanced CT Standard dose non-contrast enhanced CT: Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol |
| OG001 | Ultra-low Dose CT | Ultra low dose non-contrast enhanced CT Ultra low dose non-contrast enhanced CT: Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure |
|
|
| Primary | Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT | For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets. | 2/105 participants were not analyzed due to corrupt datasets. | Posted | Number | Intraclass correlation coefficient | 1 day |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Ultra-low Dose CT | Ultra low dose non-contrast enhanced CT Ultra low dose non-contrast enhanced CT: Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure | 0 | 105 | 0 | 105 | 0 | 105 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |