- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558792
Coronary MDCTA With Iopamidol Injection 370
October 18, 2012 updated by: Bracco Diagnostics, Inc
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- Bracco Diagnostics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isovue 370, 70 mL
iopamidol injection 370, 70 mL
|
70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Other Names:
|
Experimental: Isovue 370, 80 mL
iopamidol injection 370, 80 mL
|
80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Other Names:
|
Experimental: Isovue 370, 90 mL
iopamidol injection 370, 90 mL
|
90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Other Names:
|
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
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
Immediately post dose
|
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.
|
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
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.
|
up to 72 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jiefen Yao, M.D., Bracco Diagnostics, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- IOP 108
- NCT00558792 (Registry Identifier: clinicaltrials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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