Coronary MDCTA With Iopamidol Injection 370

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Isovue 370, 70 mL; Drug: Isovue 370, 80 mL; Drug: Isovue 370, 90 mL

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bracco Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Isovue

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 13, 2007
• First Submitted That Met QC Criteria: November 14, 2007
• First Posted (Estimate): November 15, 2007

Study Record Updates

• Last Update Posted (Estimate): October 24, 2012
• Last Update Submitted That Met QC Criteria: October 18, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IOP 108; NCT00558792 (Registry Identifier: clinicaltrials.gov)