Coronary MDCTA With Iopamidol Injection 370

Bracco

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Isovue 370, 70 mL; Drug: Isovue 370, 80 mL; Drug: Isovue 370, 90 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558792

NCT00558792 (Registry Identifier)

IOP 108

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 3 patient groups

Isovue 370, 70 mL

Experimental group

Description:

iopamidol injection 370, 70 mL

Treatment:

Drug: Isovue 370, 70 mL

Isovue 370, 80 mL

Experimental group

Description:

iopamidol injection 370, 80 mL

Treatment:

Drug: Isovue 370, 80 mL

Isovue 370, 90 mL

Experimental group

Description:

iopamidol injection 370, 90 mL

Treatment:

Drug: Isovue 370, 90 mL