Iodine Content for Diagnostic AccuRacy & Patient Comfort For Individuals

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370 mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT scanner for detection of presence or absence of coronary artery obstruction when compared against invasive coronary angiography, the standard of truth.

Clinical Trial Description

Coronary Cardiac CT (CCTA) is a widely accepted modality for non-invasive evaluation of coronary atherosclerosis. The diagnostic performance of CCTA for detecting coronary artery plaque burden has been validated in numerous studies, reaching a negative predictive value of 99%.

The current gold standard for anatomic coronary imaging is Invasive Coronary Angiography (ICA) which portends a small but significant procedural-related complication of 1.7%. Non-invasive coronary imaging has the potential to replace ICA but the variability in diagnostic performance of CCTA remains under study. Among the potential variables causing differences in diagnostic performance is perhaps the degree of opacification of coronary artery by iodinated contrast. While numerous contrast agents exist, those that provide improved low and high contrast resolution (for delineating plaque from arterial wall and lumen from plaque, respectively) are hypothetically, the most optimal agents. To date, however, this has not been well evaluated. Further, use of a contrast agent which maximizes patient comfort is desired, as this may reduce heart rate increases and heart rate variability, which may in turn improve diagnostic image quality of CCTA.

We hypothesize that the use of lower iodine content iso-osmolar agent - iodixanol - will improve diagnostic performance and patient comfort, as compared to higher iodine content low osmolar iodinated contrast - iopamidol. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01052441
Study type	Observational
Source	MDDX LLC
Contact
Status	Completed
Phase	N/A
Start date	January 2010
Completion date	September 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac Computed Tomography (CT) Scanning — ICARUS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms