Contrast Enhancement on Coronary Computed Tomographic Angiography (EICAR)

January 4, 2016 updated by: Marco Das, Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 240
Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s
Drug: 240 mg Iodine
Other Names:
  • 240 mg Iodine/ml IDR 2.0 gI/s
Experimental: 300
Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s
Drug: 300 mg Iodine
Other Names:
  • 300 mg Iodine/ml IDR 2.0 gI/s
Experimental: 370
Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s
Drug: 370 mg Iodine
Other Names:
  • 240 mg Iodine/ml IDR 2.0 gI/s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 13-1-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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