Coronary MDCTA With Iopamidol Injection 370

• ClinicalTrials.gov Identifier: NCT00558792
• Recruitment Status: Completed
• First Posted: November 15, 2007
• Results First Posted: October 19, 2012
• Last Update Posted: October 24, 2012
• Sponsor: Bracco Diagnostics, Inc
• Information provided by (Responsible Party): Bracco Diagnostics, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Isovue 370, 70 mL; Drug: Isovue 370, 80 mL; Drug: Isovue 370, 90 mL	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: 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
• Study Start Date: November 2007
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Isovue 370, 70 mL; iopamidol injection 370, 70 mL	Drug: Isovue 370, 70 mL; 70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second; Other Name: Isovue
Experimental: Isovue 370, 80 mL; iopamidol injection 370, 80 mL	Drug: Isovue 370, 80 mL; 80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second; Other Name: Isovue
Experimental: Isovue 370, 90 mL; iopamidol injection 370, 90 mL	Drug: Isovue 370, 90 mL; 90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second; Other Name: Isovue

Outcome Measures

Primary Outcome Measures :

1. Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 [ Time Frame: 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.
2. Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2 [ Time Frame: 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.
3. Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3 [ Time Frame: 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.
4. Contrast Density (CD) Measurements, Off-Site Reader 1 [ Time Frame: 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.
5. Contrast Density (CD) Measurements, Off-Site Reader 2 [ Time Frame: 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.
6. Contrast Density (CD) Measurements, Off-Site Reader 3 [ Time Frame: 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.
7. Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity [ Time Frame: 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.
8. Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity [ Time Frame: 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.
9. Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity [ Time Frame: 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.
10. Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity [ Time Frame: 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.
11. Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity [ Time Frame: 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.
12. Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity [ Time Frame: 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 :

1. Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Bracco Diagnostics

Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

• Study Director: Jiefen Yao, M.D.; Bracco Diagnostics, Inc

More Information

• Responsible Party: Bracco Diagnostics, Inc
• ClinicalTrials.gov Identifier: NCT00558792
• Other Study ID Numbers: IOP 108
• First Posted: November 15, 2007
• Results First Posted: October 19, 2012
• Last Update Posted: October 24, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases