Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT00558792 | Registry Identifier | clinicaltrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isovue 370, 70 mL | Experimental | iopamidol injection 370, 70 mL |
|
| Isovue 370, 80 mL | Experimental | iopamidol injection 370, 80 mL |
|
| Isovue 370, 90 mL | Experimental | iopamidol injection 370, 90 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isovue 370, 70 mL | Drug | 70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Immediately post dose |
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Immediately post dose |
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Immediately post dose |
| Contrast Density (CD) Measurements, Off-Site Reader 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details. | up to 72 hours post dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiefen Yao, M.D. | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics | Princeton | New Jersey | 08540 | United States |
This was a Phase II, multicenter, prospective, double-blind, randomized, parallel-group comparison of 3 doses of iopamidol injection 370 when used for coronary MDCTA.
Patients were enrolled from December 2007 to December 2009 in 17 investigational sites across the United States of America (USA), 2 investigational sites in Canada and 2 investigational sites in Italy. A blinded read of the images obtained during the study was performed in May 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Isovue 370, 70 mL | iopamidol injection 370, 70 mL |
| FG001 | Isovue 370, 80 mL | iopamidol injection 370, 80 mL |
| FG002 | Isovue 370, 90 mL | iopamidol injection 370, 90 mL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Isovue 370, 70 mL | iopamidol injection 370, 70 mL |
| BG001 | Isovue 370, 80 mL | iopamidol injection 370, 80 mL |
| 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 | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Posted | Number | Segments Visualized Accurately | Immediately post dose | Segments Present & Technically Adequate | Participants |
|
Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370.
Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isovue 370, 70 mL | iopamidol injection 370, 70 mL |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling Hot | General disorders | MedDRA version 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Usha Halemane, Executive Director of Medical Biometrics and Medical Writing | Bracco Diagnostics Inc | 609-514-2578 | usha.halemane@diag.bracco.com |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Isovue 370, 80 mL | Drug | 80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second |
|
|
| Isovue 370, 90 mL | Drug | 90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second |
|
|
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. |
| Immediately post dose |
| Contrast Density (CD) Measurements, Off-Site Reader 2 | For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. | Immediately post dose |
| Contrast Density (CD) Measurements, Off-Site Reader 3 | For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Immediately post dose |
| Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Immediately post dose |
| BG002 |
| Isovue 370, 90 mL |
iopamidol injection 370, 90 mL |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Isovue 370, 80 mL | Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate. |
| OG002 | Isovue 370, 90 mL | Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate. |
|
|
|
| Primary | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Posted | Number | Segments Visualized Accurately | Immediately post dose | Segments | Participants |
|
|
|
|
| Primary | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque. | Posted | Number | Segments Visualized Accurately | Immediately post dose | Segments Present & Technically Adequate | Participants |
|
|
|
|
| Secondary | Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details. | Posted | Number | Participants who Experienced AE(s) | up to 72 hours post dose |
|
|
|
| Primary | Contrast Density (CD) Measurements, Off-Site Reader 1 | For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. | Posted | Mean | Standard Deviation | Hounsfield Units | Immediately post dose |
|
|
|
|
| Primary | Contrast Density (CD) Measurements, Off-Site Reader 2 | For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. | Posted | Mean | Standard Deviation | Hounsfield Units | Immediately post dose |
|
|
|
|
| Primary | Contrast Density (CD) Measurements, Off-Site Reader 3 | For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader. | Posted | Mean | Standard Deviation | Hounsfield Units | Immediately post dose |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Sensitivity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Specificity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Sensitivity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Specificity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Sensitivity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| Primary | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented. | Number of participants with significant disease (>50% stenosis) | Posted | Number | Specificity (%) | Immediately post dose | Vessels | Participants |
|
|
|
|
| 0 |
| 68 |
| 15 |
| 68 |
| EG001 | Isovue 370, 80 mL | iopamidol injection 370, 80 mL | 0 | 63 | 14 | 63 |
| EG002 | Isovue 370, 90 mL | iopamidol injection 370, 90 mL | 0 | 60 | 13 | 60 |
| Flushing | Vascular disorders | MedDRA version 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 12.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA version 12.1 | Systematic Assessment |
|
The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Chi-squared |
| 0.3102 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Sensitivity between Doses |
| 12.3 |
| 2-Sided |
| 95 |
| -11.1 |
| 35.6 |
| No |
| Superiority or Other |
| Chi-squared | 0.8893 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Sensitivity between Doses | 1.9 | 2-Sided | 95 | -24.6 | 28.4 | No | Superiority or Other |
| Chi-squared |
| 0.4985 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Specificity between Doses |
| 1.3 |
| 2-Sided |
| 95 |
| -2.6 |
| 5.3 |
| No |
| Superiority or Other |
| Chi-squared | 0.0693 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Specificity between Doses | -3.1 | 2-Sided | 95 | -6.5 | 0.4 | No | Superiority or Other |
| Chi-squared |
| 0.2857 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Sensitivity between Doses |
| -12.6 |
| 2-Sided |
| 95 |
| -35.7 |
| 10.5 |
| No |
| Superiority or Other |
| Chi-squared | 0.3664 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Sensitivity between Doses | 11.1 | 2-Sided | 95 | -13.3 | 35.5 | No | Superiority or Other |
| Chi-squared |
| 0.6381 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Specificity between Doses |
| -1.3 |
| 2-Sided |
| 95 |
| -6.9 |
| 4.2 |
| No |
| Superiority or Other |
| Chi-squared | 0.3217 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Specificity between Doses | -2.4 | 2-Sided | 95 | -7.2 | 2.4 | No | Superiority or Other |
| Chi-squared |
| 0.7197 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Sensitivity between Doses |
| 4.6 |
| 2-Sided |
| 95 |
| -20.5 |
| 29.7 |
| No |
| Superiority or Other |
| Chi-squared | 0.8292 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Sensitivity between Doses | 3.0 | 2-Sided | 95 | -24.1 | 30.1 | No | Superiority or Other |
| Chi-squared |
| 0.7796 |
Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. |
| Difference in Specificity between Doses |
| -0.8 |
| 2-Sided |
| 95 |
| -6.4 |
| 4.8 |
| No |
| Superiority or Other |
| Chi-squared | 0.1662 | Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments. | Difference in Specificity between Doses | -3.4 | 2-Sided | 95 | -8.2 | 1.5 | No | Superiority or Other |