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

Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Computed Tomographic Angiography
• Intervention / Treatment: Drug: Isovue 370; Drug: Visipaque 320

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Isovue 370; Isovue 370 is a contrast agent with increased iodine concentration.	Drug: Isovue 370; Isovue 370 is a contrast agent with increased iodine concentration.
Active Comparator: Visipaque 320; Standard protocol is Visipaque 320.	Drug: Visipaque 320; Visipaque 320 is standard protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast to Noise Ratio	Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.	during scan, approximately 3 hours
Image Quality	Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.	during scan, approximately 3 hours
Motion Artifact	The outcome will be measured by individual scores. The scores from multiple readers will be averaged.	during scan, approximately 3 hours
Attenuation of the Ascending Aorta and Coronary Arteries	The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.	during scan, approximately 3 hours

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Daniel T Boll, MD, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: July 28, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: contrast; coronary computed tomographic angiography
• Other Study ID Numbers: Pro00004492