Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

Duke University

Status and phase: Completed; Phase 3

Conditions: Coronary Computed Tomographic Angiography

Treatments: Drug: Visipaque 320; Drug: Isovue 370

Study type: Interventional

Funder types: Other

Identifiers

NCT02171247

Pro00004492

Details and patient eligibility

About

Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion criteria

• creatinine greater than 2.0
• allergy to contrast media
• patients under the age of 18
• women who are pregnant or breast feeding
• patients with cardiac arrhythmia will also be excluded

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Isovue 370

Active Comparator group

Description:

Isovue 370 is a contrast agent with increased iodine concentration.

Treatment:

Drug: Isovue 370

Visipaque 320

Active Comparator group

Description:

Standard protocol is Visipaque 320.

Treatment:

Drug: Visipaque 320