Coronary Artery DiseasePhase 4EICARNCT02462044
Contrast Enhancement on Coronary Computed Tomographic Angiography
A Phase 4 study testing 240 mg Iodine, 300 mg Iodine and 370 mg Iodine in people with Coronary Artery Disease and Coronary Stenosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- 240 mg Iodine, 300 mg Iodine and 370 mg Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atypical or typical chest pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Being tested
- 240 mg Iodine, 300 mg Iodine, 370 mg Iodine
- Keywords
- Computed tomography, Coronary CTA, Contrast media
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
240 mg IodineDrug
Also called 240 mg Iodine/ml IDR 2.0 gI/s
300 mg IodineDrug
Also called 300 mg Iodine/ml IDR 2.0 gI/s
370 mg IodineDrug
Also called 240 mg Iodine/ml IDR 2.0 gI/s
| Study group | Role | What they receive |
|---|---|---|
| 240 | Experimental | Group 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s Receives: Drug: 240 mg Iodine |
| 300 | Experimental | Group 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s Receives: Drug: 300 mg Iodine |
| 370 | Experimental | Group 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s Receives: Drug: 370 mg Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (3)
time to peak
Effect of iodine concentration - as measured by dedicated contrast monitoring software.
Measured: two years
bolus homogeneity
Effect on contrast bolus characteristics and injection pressure - as measured by dedicated contrast monitoring software.
Measured: two years
patient comfort
Effect on patient comfort. As assessed by patient questionnaire.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Marco Das, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462044
- Sponsor's protocol ID
- METC 13-1-033
- Acronym
- EICAR
- Status last verified
- Jan 2016
- First submitted
- 9 Sep 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhancement on Coronary Computed Tomographic Angiography : Effects on Intra-Coronary Attenuation Using Low Iodine Concentrations While Maintaining Identical IDR (EICAR-Trial)
- ClinicalTrials.gov ID
- NCT02462044
- Acronym / sponsor ID
- EICAR / METC 13-1-033
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Keywords
- Computed tomography, Coronary CTA, Contrast media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 240 | Experimental | Drug: 240 mg IodineGroup 240 will receive CM with 240 mg Iodine/ml IDR 2.0 gI/s |
| 300 | Experimental | Drug: 300 mg IodineGroup 300 will receive CM with 300 mg Iodine/ml IDR 2.0 gI/s |
| 370 | Experimental | Drug: 370 mg IodineGroup 370 will receive CM with 370 mg Iodine/ml IDR 2.0 gI/s |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atypical or typical chest pain
Key exclusion criteria (6 listed)
- Unstable angina
- Hemodynamic instability
- History of CAD
- Pregnancy
- Renal insufficiency (defined as glomerular filtration rate (GFR) <45ml/min or <60ml +diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 240 mg IodineAlso: 240 mg Iodine/ml IDR 2.0 gI/s | Drug | 240 |
| 300 mg IodineAlso: 300 mg Iodine/ml IDR 2.0 gI/s | Drug | 300 |
| 370 mg IodineAlso: 240 mg Iodine/ml IDR 2.0 gI/s | Drug | 370 |
Primary outcome
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.
3 secondary outcomes
time to peak
Time frame: two years
bolus homogeneity
Time frame: two years
patient comfort
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 240 mg Iodine, 300 mg Iodine and 370 mg Iodine in people with Coronary Artery Disease and Coronary Stenosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravascular contrast enhancement (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.