Contrast Enhancement on Coronary Computed Tomographic Angiography

Phase 4

Completed

• Conditions: Coronary Stenosis; Coronary Artery Disease
• Interventions: Drug: 300 mg Iodine; Drug: 240 mg Iodine; Drug: 370 mg Iodine

• Registration Number: NCT02462044
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
300	300 mg Iodine	Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s
240	240 mg Iodine	Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s
370	370 mg Iodine	Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
patient comfort	two years	Effect on patient comfort. As assessed by patient questionnaire.
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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands