Coronary MDCTA With Iopamidol Injection 370 - Full Text View

Purpose

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	Intervention	Phase
Coronary Artery Disease	Drug: Isovue 370, 70 mL Drug: Isovue 370, 80 mL Drug: Isovue 370, 90 mL	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Iopamidol

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Immediately post dose ] [ Designated as safety issue: No ]
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:

Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: No ]
Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.

Enrollment:	210
Study Start Date:	November 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558792

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

No publications provided

Responsible Party:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00558792 History of Changes
Other Study ID Numbers:	IOP 108
Study First Received:	November 13, 2007
Results First Received:	August 13, 2012
Last Updated:	October 18, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013