Contrast Enhancement on Coronary Computed Tomographic Angiography (EICAR)

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Coronary Stenosis

Treatments: Drug: 240 mg Iodine; Drug: 370 mg Iodine; Drug: 300 mg Iodine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02462044

METC 13-1-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 3 patient groups

240

Experimental group

Description:

Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s

Treatment:

Drug: 240 mg Iodine

300

Experimental group

Description:

Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s

Treatment:

Drug: 300 mg Iodine

370

Experimental group

Description:

Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s

Treatment:

Drug: 370 mg Iodine