NCT02462044

Contrast Enhancement on Coronary Computed Tomographic Angiography

Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels. There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations. To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.

Detailed description

To evaluate intravascular contrast enhancement and image quality in coronary CTA using different iodine concentrations ranging from 240 to 370 mg iodine per ml, administered with an identical IDR and total iodine load. To describe the effect of iodine concentration and flow rates on contrast bolus characteristics, eg time to peak, bolus homogeneity, injection pressure and patient comfort.

Conditions

• Coronary Artery Disease
• Coronary Stenosis

Interventions

Type	Name	Description
DRUG	240 mg Iodine
DRUG	300 mg Iodine
DRUG	370 mg Iodine

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-06-03
• Last updated: 2016-01-05

Locations

1 site across 1 country: Netherlands