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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Hx of hypersensitivity to iodinated contrast agents
- •Known or suspected hyperthyroidism or pheochromocytoma
- •Renal impairment
- •History of coronary artery stent placement or bypass grafts
- •Pregnant or lactating
研究组 & 干预措施
Isovue 370, 70 mL
iopamidol injection 370, 70 mL
干预措施: Isovue 370, 70 mL (Drug)
Isovue 370, 80 mL
iopamidol injection 370, 80 mL
干预措施: Isovue 370, 80 mL (Drug)
Isovue 370, 90 mL
iopamidol injection 370, 90 mL
干预措施: Isovue 370, 90 mL (Drug)
结局指标
主要结局
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater(up to 72 hours post dose)