Coronary MDCTA With Iopamidol Injection 370

NCT00558792 | Completed Phase 2 Results

• 2 other identifiers: IOP 108NCT00558792
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater

  up to 72 hours post dose

Study Arms (3)

Isovue 370, 70 mL

EXPERIMENTAL

iopamidol injection 370, 70 mL

Drug: Isovue 370, 70 mL

Isovue 370, 80 mL

EXPERIMENTAL

iopamidol injection 370, 80 mL

Drug: Isovue 370, 80 mL

Isovue 370, 90 mL

EXPERIMENTAL

iopamidol injection 370, 90 mL

Drug: Isovue 370, 90 mL

Interventions

Isovue 370, 70 mL DRUG

70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second

Also known as: Isovue

Isovue 370, 70 mL

Isovue 370, 80 mL DRUG

80 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second

Also known as: Isovue

Isovue 370, 80 mL

Isovue 370, 90 mL DRUG

90 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second

Also known as: Isovue

Isovue 370, 90 mL

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Iopamidol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Usha Halemane, Executive Director of Medical Biometrics and Medical Writing
• Organization: Bracco Diagnostics Inc

usha.halemane@diag.bracco.com

609-514-2578

Study Officials

• Jiefen Yao, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 15, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 24, 2012
• Results First Posted: October 19, 2012

Record last verified: 2012-10

Locations

US (1)