Coronary MDCTA With Iopamidol Injection 370
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Isovue 370, 70 mLDrug: Isovue 370, 80 mLDrug: Isovue 370, 90 mL
- Registration Number
- NCT00558792
- Lead Sponsor
- Bracco Diagnostics, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isovue 370, 70 mL Isovue 370, 70 mL iopamidol injection 370, 70 mL Isovue 370, 80 mL Isovue 370, 80 mL iopamidol injection 370, 80 mL Isovue 370, 90 mL Isovue 370, 90 mL iopamidol injection 370, 90 mL
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Bracco Diagnostics
🇺🇸Princeton, New Jersey, United States