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Contrast Enhancement on Coronary Computed Tomographic Angiography (EICAR)

Primary Purpose

Coronary Artery Disease, Coronary Stenosis

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

240 mg Iodine

300 mg Iodine

370 mg Iodine

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Computed tomography, Coronary CTA, Contrast media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

240

300

370

Arm Description

Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s

Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s

Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

time to peak

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

bolus homogeneity

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

patient comfort

Effect on patient comfort. As assessed by patient questionnaire.

Full Information

NCT ID

NCT02462044

First Posted

September 9, 2014

Last Updated

January 4, 2016

Sponsor

Maastricht University Medical Center

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02462044

Brief Title

Contrast Enhancement on Coronary Computed Tomographic Angiography

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Stenosis

Keywords

Computed tomography, Coronary CTA, Contrast media

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

240

Arm Type

Experimental

Arm Description

Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s

Arm Title

300

Arm Type

Experimental

Arm Description

Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s

Arm Title

370

Arm Type

Experimental

Arm Description

Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s

Intervention Type

Drug

Intervention Name(s)

240 mg Iodine

Other Intervention Name(s)

240 mg Iodine/ml IDR 2.0 gI/s

Intervention Type

Drug

Intervention Name(s)

300 mg Iodine

Other Intervention Name(s)

300 mg Iodine/ml IDR 2.0 gI/s

Intervention Type

Drug

Intervention Name(s)

370 mg Iodine

Other Intervention Name(s)

240 mg Iodine/ml IDR 2.0 gI/s

Primary Outcome Measure Information:

Title

intravascular contrast enhancement

Description

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.

Time Frame

two years

Secondary Outcome Measure Information:

Title

time to peak

Description

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

Time Frame

two years

Title

bolus homogeneity

Description

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

Time Frame

two years

Title

patient comfort

Description

Effect on patient comfort. As assessed by patient questionnaire.

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

ZIP/Postal Code

6202AZ

Country

Netherlands

12. IPD Sharing Statement

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