Contrast Enhancement on Coronary Computed Tomographic Angiography

Coronary Artery Disease Clinical Trial

— EICAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462044
• Other study ID #: METC 13-1-033
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2014
• Last updated: January 4, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Drug:
• 240 mg Iodine

• 300 mg Iodine

• 370 mg Iodine

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intravascular contrast enhancement	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.	two years	No
Secondary	time to peak	Effect of iodine concentration - as measured by dedicated contrast monitoring software.	two years	No
Secondary	bolus homogeneity	Effect on contrast bolus characteristics and injection pressure - as measured by dedicated contrast monitoring software.	two years	No
Secondary	patient comfort	Effect on patient comfort. As assessed by patient questionnaire.	two years	No

External Links

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