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Contrast Enhancement on Coronary Computed Tomographic Angiography (EICAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02462044
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : January 5, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Marco Das, 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Stenosis Drug: 240 mg Iodine Drug: 300 mg Iodine Drug: 370 mg Iodine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)
Study Start Date : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

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 Name: 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 Name: 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 Name: 240 mg Iodine/ml IDR 2.0 gI/s




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462044


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
Bayer

Additional Information:
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Responsible Party: Marco Das, Marco Das, MD, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02462044    
Other Study ID Numbers: METC 13-1-033
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by Marco Das, Maastricht University Medical Center:
Computed tomography
Coronary CTA
Contrast media
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs