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Completed

NCT Number: NCT02462044

Contrast Enhancement on Coronary Computed Tomographic Angiography

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Center

Maastricht, 6202AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

240 mg Iodine

Drug

Other names: 240 mg Iodine/ml IDR 2.0 gI/s

300 mg Iodine

Drug

Other names: 300 mg Iodine/ml IDR 2.0 gI/s

370 mg Iodine

Drug

Other names: 240 mg Iodine/ml IDR 2.0 gI/s

Primary outcomes

  1. 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.

Secondary outcomes

  1. time to peak

    Time frame: two years

    Effect of iodine concentration - as measured by dedicated contrast monitoring software.

  2. bolus homogeneity

    Time frame: two years

    Effect on contrast bolus characteristics and injection pressure - as measured by dedicated contrast monitoring software.

  3. patient comfort

    Time frame: two years

    Effect on patient comfort. As assessed by patient questionnaire.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: EICAR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2015
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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