Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2007-11-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Isovue 370, 70 mL
iopamidol injection 370, 70 mL
Isovue 370, 70 mL
70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Isovue 370, 80 mL
iopamidol injection 370, 80 mL
Isovue 370, 80 mL
80 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Isovue 370, 90 mL
iopamidol injection 370, 90 mL
Isovue 370, 90 mL
90 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Interventions
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Isovue 370, 70 mL
70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Isovue 370, 80 mL
80 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Isovue 370, 90 mL
90 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known or suspected hyperthyroidism or pheochromocytoma
* Renal impairment
* History of coronary artery stent placement or bypass grafts
* Unstable
* Pregnant or lactating
30 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jiefen Yao, M.D.
Role: STUDY_DIRECTOR
Bracco Diagnostics, Inc
Locations
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Bracco Diagnostics
Princeton, New Jersey, United States
Countries
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Other Identifiers
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NCT00558792
Identifier Type: REGISTRY
Identifier Source: secondary_id
IOP 108
Identifier Type: -
Identifier Source: org_study_id