Coronary MDCTA With Iopamidol Injection 370

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Multicenter Randomized Double Blind Dose Finding Study of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients With Suspected Coronary Artery Stenosis

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Isovue 370, 70 mL
* Drug: Isovue 370, 80 mL
* Drug: Isovue 370, 90 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isovue 370, 70 mL<br>iopamidol injection 370, 70 mL | Drug: Isovue 370, 70 mL<br>* 70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second<br>* Other names: Isovue;|
| Experimental: Isovue 370, 80 mL<br>iopamidol injection 370, 80 mL | Drug: Isovue 370, 80 mL<br>* 80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second<br>* Other names: Isovue;|
| Experimental: Isovue 370, 90 mL<br>iopamidol injection 370, 90 mL | Drug: Isovue 370, 90 mL<br>* 90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second<br>* Other names: Isovue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |