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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Coronary Computed Tomographic Angiography

Intervention / Treatment
-----------------
* Drug: Isovue 370
* Drug: Visipaque 320


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isovue 370<br>Isovue 370 is a contrast agent with increased iodine concentration. | Drug: Isovue 370<br>* Isovue 370 is a contrast agent with increased iodine concentration.<br>|
| Active Comparator: Visipaque 320<br>Standard protocol is Visipaque 320. | Drug: Visipaque 320<br>* Visipaque 320 is standard protocol.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary computed tomographic angiography, contrast