Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)
Overview
- Phase
- Phase 4
- Intervention
- 240 mg Iodine
- Conditions
- Coronary Artery Disease
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- intravascular contrast enhancement
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Marco Das
Marco Das, MD, PhD
Maastricht University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Atypical or typical chest pain
Exclusion Criteria
- •Unstable angina
- •Hemodynamic instability
- •History of CAD
- •Pregnancy
- •Renal insufficiency (defined as glomerular filtration rate (GFR) \<45ml/min or \<60ml +diabetes
- •HR \> 90 bpm and the inability to receive beta-blockers and iodine allergy
Arms & Interventions
240
Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s
Intervention: 240 mg Iodine
300
Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s
Intervention: 300 mg Iodine
370
Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s
Intervention: 370 mg Iodine
Outcomes
Primary Outcomes
intravascular contrast enhancement
Time Frame: two years
intravascular contrast enhancement and image quality based on different contrast media (240, 300, 370) as measured by circular ROI in the target vessels using dedicated post processing.
Secondary Outcomes
- patient comfort(two years)
- time to peak(two years)
- bolus homogeneity(two years)