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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02462044

Acronym

EICAR

Enrollment

200

Registered

2015-06-03

Start date

2014-08-31

Completion date

2015-09-30

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis

Keywords

Computed tomography, Coronary CTA, Contrast media

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.

Interventions

DRUG240 mg Iodine

DRUG300 mg Iodine

DRUG370 mg Iodine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
intravascular contrast enhancement	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

Measure	Time frame	Description
time to peak	two years	Effect of iodine concentration - as measured by dedicated contrast monitoring software.
bolus homogeneity	two years	Effect on contrast bolus characteristics and injection pressure - as measured by dedicated contrast monitoring software.
patient comfort	two years	Effect on patient comfort. As assessed by patient questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026