Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
DRUGIsovue 370, 70 mL
70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
DRUGIsovue 370, 80 mL
80 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
DRUGIsovue 370, 90 mL
90 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide informed consent * At least 30 years of age * Weight less than 250 lbs * Known or suspected coronary artery disease and suspected to have significant coronary artery stenosis * Undergo MDCTA scan * Undergo coronary angiography within 2 weeks of MDCTA scan
Exclusion criteria
* Hx of hypersensitivity to iodinated contrast agents * Known or suspected hyperthyroidism or pheochromocytoma * Renal impairment * History of coronary artery stent placement or bypass grafts * Unstable * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | Immediately post dose | 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. |
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | Immediately post dose | 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. |
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | Immediately post dose | 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. |
| Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | Immediately post dose | 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. |
| Contrast Density (CD) Measurements, Off-Site Reader 1 | Immediately post dose | 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. |
| Contrast Density (CD) Measurements, Off-Site Reader 2 | Immediately post dose | 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. |
| Contrast Density (CD) Measurements, Off-Site Reader 3 | Immediately post dose | 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. |
| Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | Immediately post dose | 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. |
| Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | Immediately post dose | 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. |
| Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | Immediately post dose | 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. |
| Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | Immediately post dose | 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. |
| Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | Immediately post dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | up to 72 hours post dose | Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Isovue 370, 70 mL iopamidol injection 370, 70 mL | 68 |
| Isovue 370, 80 mL iopamidol injection 370, 80 mL | 63 |
| Isovue 370, 90 mL iopamidol injection 370, 90 mL | 60 |
| Total | 191 |
Baseline characteristics
| Characteristic | Isovue 370, 70 mL | Isovue 370, 80 mL | Isovue 370, 90 mL | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 14 Participants | 18 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 49 Participants | 42 Participants | 144 Participants |
| Age Continuous | 57.7 years STANDARD_DEVIATION 8.85 | 57.7 years STANDARD_DEVIATION 8.54 | 58.7 years STANDARD_DEVIATION 9.25 | 58.0 years STANDARD_DEVIATION 8.85 |
| Region of Enrollment Canada | 11 participants | 10 participants | 10 participants | 31 participants |
| Region of Enrollment Italy | 2 participants | 3 participants | 2 participants | 7 participants |
| Region of Enrollment United States | 55 participants | 50 participants | 48 participants | 153 participants |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 21 Participants | 73 Participants |
| Sex: Female, Male Male | 43 Participants | 36 Participants | 39 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 68 | 14 / 63 | 13 / 60 |
| serious Total, serious adverse events | 0 / 68 | 0 / 63 | 0 / 60 |
Outcome results
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.
Time frame: Immediately post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isovue 370, 70 mL | Contrast Density (CD) Measurements, Off-Site Reader 1 | 372.806 Hounsfield Units | Standard Deviation 90.5842 |
| Isovue 370, 80 mL | Contrast Density (CD) Measurements, Off-Site Reader 1 | 398.255 Hounsfield Units | Standard Deviation 82.3593 |
| Isovue 370, 90 mL | Contrast Density (CD) Measurements, Off-Site Reader 1 | 418.197 Hounsfield Units | Standard Deviation 97.4072 |
p-value: 0.02ANOVA
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.
Time frame: Immediately post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isovue 370, 70 mL | Contrast Density (CD) Measurements, Off-Site Reader 2 | 364.784 Hounsfield Units | Standard Deviation 78.2154 |
| Isovue 370, 80 mL | Contrast Density (CD) Measurements, Off-Site Reader 2 | 396.291 Hounsfield Units | Standard Deviation 85.7038 |
| Isovue 370, 90 mL | Contrast Density (CD) Measurements, Off-Site Reader 2 | 413.665 Hounsfield Units | Standard Deviation 86.0972 |
p-value: 0.0044ANOVA
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.
Time frame: Immediately post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isovue 370, 70 mL | Contrast Density (CD) Measurements, Off-Site Reader 3 | 363.071 Hounsfield Units | Standard Deviation 85.7795 |
| Isovue 370, 80 mL | Contrast Density (CD) Measurements, Off-Site Reader 3 | 383.841 Hounsfield Units | Standard Deviation 96.8142 |
| Isovue 370, 90 mL | Contrast Density (CD) Measurements, Off-Site Reader 3 | 406.206 Hounsfield Units | Standard Deviation 91.9117 |
p-value: 0.0371ANOVA
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.
Time frame: Immediately post dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | 949 Segments Visualized Accurately |
| Isovue 370, 80 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | 842 Segments Visualized Accurately |
| Isovue 370, 90 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 | 841 Segments Visualized Accurately |
p-value: 0.0099Chi-squared
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.
Time frame: Immediately post dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | 1032 Segments Visualized Accurately |
| Isovue 370, 80 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | 924 Segments Visualized Accurately |
| Isovue 370, 90 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 | 927 Segments Visualized Accurately |
p-value: <0.0001Chi-squared
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.
Time frame: Immediately post dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | 925 Segments Visualized Accurately |
| Isovue 370, 80 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | 824 Segments Visualized Accurately |
| Isovue 370, 90 mL | Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 | 817 Segments Visualized Accurately |
p-value: 0.1212Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | 63.6 Sensitivity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | 65.5 Sensitivity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity | 77.8 Sensitivity (%) |
p-value: 0.275895% CI: [-11.4, 39.6]Chi-squared
p-value: 0.310295% CI: [-11.1, 35.6]Chi-squared
p-value: 0.889395% CI: [-24.6, 28.4]Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | 98.3 Specificity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | 95.2 Specificity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity | 96.6 Specificity (%) |
p-value: 0.251195% CI: [-4.7, 1.3]Chi-squared
p-value: 0.498595% CI: [-2.6, 5.3]Chi-squared
p-value: 0.069395% CI: [-6.5, 0.4]Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | 68.2 Sensitivity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | 79.3 Sensitivity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity | 66.7 Sensitivity (%) |
p-value: 0.910495% CI: [-27.9, 24.8]Chi-squared
p-value: 0.285795% CI: [-35.7, 10.5]Chi-squared
p-value: 0.366495% CI: [-13.3, 35.5]Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | 94.5 Specificity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | 92.1 Specificity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity | 90.7 Specificity (%) |
p-value: 0.132295% CI: [-8.7, 1.2]Chi-squared
p-value: 0.638195% CI: [-6.9, 4.2]Chi-squared
p-value: 0.321795% CI: [-7.2, 2.4]Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | 59.1 Sensitivity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | 62.1 Sensitivity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity | 66.7 Sensitivity (%) |
p-value: 0.584395% CI: [-19.6, 34.7]Chi-squared
p-value: 0.719795% CI: [-20.5, 29.7]Chi-squared
p-value: 0.829295% CI: [-24.1, 30.1]Chi-squared
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.
Time frame: Immediately post dose
Population: Number of participants with significant disease (\>50% stenosis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | 94.9 Specificity (%) |
| Isovue 370, 80 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | 91.5 Specificity (%) |
| Isovue 370, 90 mL | Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity | 90.7 Specificity (%) |
p-value: 0.088895% CI: [-9, 0.7]Chi-squared
p-value: 0.779695% CI: [-6.4, 4.8]Chi-squared
p-value: 0.166295% CI: [-8.2, 1.5]Chi-squared
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.
Time frame: up to 72 hours post dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 370, 70 mL | Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | 15 Participants who Experienced AE(s) |
| Isovue 370, 80 mL | Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | 14 Participants who Experienced AE(s) |
| Isovue 370, 90 mL | Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater | 13 Participants who Experienced AE(s) |