Coronary ArteriosclerosisICARUSNCT01052441
Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac Computed Tomography (CT) Scanning
An observational study of Coronary Arteriosclerosis, run by MDDX LLC at 3 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370 mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT scanner for detection of presence or absence of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis
- How many people
- 250 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2010to Sep 2012
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are over 18 years or older. They have been referred to a cardiologist for suspected CAD and then scheduled for an elective invasive coronary angiography.
Who may be able to join
- The subject is ≥18 years old.
- The subject has typical or atypical chest pain suspected of Coronary Artery Disease (CAD) and is referred for an elective coronary angiography.
- The subject must be scheduled to undergo a CATH procedure between 72 hours and 3 weeks of the CCTA procedure.
- The subject must not undergo any cardiac interventional treatment between the 2 procedures.
- The subject must have a sinus rhythm with stable heart rate of ≤75 beats per minute (bpm) and if heart rate is >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.
Who cannot join
- The subject has an established diagnosis of CAD by a) previous ICA, b) prior myocardial infarction confirmed by electrocardiogram (ECG), or c) prior revascularization (balloon angioplasty, stent placement, or coronary artery bypass grafting (CABG).
- The subject has a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
- The subject has impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
- The subject has atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
- The subject has a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100 mm Hg.
- The subject has an artificial heart valve(s).
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- The subject has had prior pacemaker or internal defibrillator lead implantation.
- The subject's resting heart rate is >65 bpm and beta-blocker therapy is contraindicated.
- The subject has a contraindication to Verapamil when beta-blocker therapy cannot be administered.
- The subject has a contraindication to nitroglycerin.
- The subject has evidence of ongoing or active clinical instability.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Capital Cardiology Associates
Albany, New York, 12211
Hudson Valley Heart Center
Poughkeepsie, New York, 12601
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac CT Scanning: The Multicenter ICARUS Trial
The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370 mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT scanner for detection of presence or absence of coronary artery obstruction when compared against invasive coronary angiography, the standard of truth.
Read the detailed description
Coronary Cardiac CT (CCTA) is a widely accepted modality for non-invasive evaluation of coronary atherosclerosis. The diagnostic performance of CCTA for detecting coronary artery plaque burden has been validated in numerous studies, reaching a negative predictive value of 99%.
The current gold standard for anatomic coronary imaging is Invasive Coronary Angiography (ICA) which portends a small but significant procedural-related complication of 1.7%. Non-invasive coronary imaging has the potential to replace ICA but the variability in diagnostic performance of CCTA remains under study. Among the potential variables causing differences in diagnostic performance is perhaps the degree of opacification of coronary artery by iodinated contrast. While numerous contrast agents exist, those that provide improved low and high contrast resolution (for delineating plaque from arterial wall and lumen from plaque, respectively) are hypothetically, the most optimal agents. To date, however, this has not been well evaluated. Further, use of a contrast agent which maximizes patient comfort is desired, as this may reduce heart rate increases and heart rate variability, which may in turn improve diagnostic image quality of CCTA.
We hypothesize that the use of lower iodine content iso-osmolar agent - iodixanol - will improve diagnostic performance and patient comfort, as compared to higher iodine content low osmolar iodinated contrast - iopamidol.
- Conditions
- Coronary Arteriosclerosis
- Keywords
- CCTA, Coronary Artery Stenosis, Iodinated Contrast, Invasive Coronary Angiography
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CT Scan | Subjects with typical or atypical chest pain suspected of coronary artery disease and referred for an elective invasive coronary angiography (ICA), and scheduled to undergo CCTA before ICA or after ICA, if no intervention has been performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for coronary artery stenosis detection at the per-segment, per-vessel and per-patient level using an 18-coronary artery segment model as defined by Society of Cardiovascular Computed Tomography (SCCT), as compared to ICA.
Measured: 72 hours
Secondary outcomes (1)
Heart rate increase and variability during contrast injection. Rates of 7-day contrast-induced nephropathy. Any untoward adverse reactions like flushing, itching, nausea/vomiting etc
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MDDX LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Robert Benton, MD, Principal investigator, Capital Cardiology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052441
- Sponsor's protocol ID
- GEH-CRLLC-1.2009
- Acronym
- ICARUS
- Status last verified
- Dec 2012
- First submitted
- 14 Jan 2010
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
PubMed 19038879
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac CT Scanning: The Multicenter ICARUS Trial
- ClinicalTrials.gov ID
- NCT01052441
- Acronym / sponsor ID
- ICARUS / GEH-CRLLC-1.2009
- Conditions
- Coronary Arteriosclerosis
- Keywords
- CCTA, Coronary Artery Stenosis, Iodinated Contrast, Invasive Coronary Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- MDDX LLCIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jan 2010 (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.
The purpose of the study is to evaluate diagnostic performance of high iodine (iopamidol 370 mg/dl) content versus low iodine (iodixanol 300 mg/dl) content for diagnostic accuracy by contrast-enhanced Coronary Cardiac Computed Tomography (CCTA) using a 64-detector-row CT scanner for detection of presence or absence of coronary artery obstruction when compared against invasive coronary angiography, the standard of truth.
Detailed description
Coronary Cardiac CT (CCTA) is a widely accepted modality for non-invasive evaluation of coronary atherosclerosis. The diagnostic performance of CCTA for detecting coronary artery plaque burden has been validated in numerous studies, reaching a negative predictive value of 99%.
The current gold standard for anatomic coronary imaging is Invasive Coronary Angiography (ICA) which portends a small but significant procedural-related complication of 1.7%. Non-invasive coronary imaging has the potential to replace ICA but the variability in diagnostic performance of CCTA remains under study. Among the potential variables causing differences in diagnostic performance is perhaps the degree of opacification of coronary artery by iodinated contrast. While numerous contrast agents exist, those that provide improved low and high contrast resolution (for delineating plaque from arterial wall and lumen from plaque, respectively) are hypothetically, the most optimal agents. To date, however, this has not been well evaluated. Further, use of a contrast agent which maximizes patient comfort is desired, as this may reduce heart rate increases and heart rate variability, which may in turn improve diagnostic image quality of CCTA.
We hypothesize that the use of lower iodine content iso-osmolar agent - iodixanol - will improve diagnostic performance and patient comfort, as compared to higher iodine content low osmolar iodinated contrast - iopamidol.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Scan | – | –Subjects with typical or atypical chest pain suspected of coronary artery disease and referred for an elective invasive coronary angiography (ICA), and scheduled to undergo CCTA before ICA or after ICA, if no intervention has been performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are over 18 years or older. They have been referred to a cardiologist for suspected CAD and then scheduled for an elective invasive coronary angiography.
Key inclusion criteria (5 listed)
- The subject is ≥18 years old.
- The subject has typical or atypical chest pain suspected of Coronary Artery Disease (CAD) and is referred for an elective coronary angiography.
- The subject must be scheduled to undergo a CATH procedure between 72 hours and 3 weeks of the CCTA procedure.
- The subject must not undergo any cardiac interventional treatment between the 2 procedures.
- The subject must have a sinus rhythm with stable heart rate of ≤75 beats per minute (bpm) and if heart rate is >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.
Key exclusion criteria (11 listed)
- The subject has an established diagnosis of CAD by a) previous ICA, b) prior myocardial infarction confirmed by electrocardiogram (ECG), or c) prior revascularization (balloon angioplasty, stent placement, or coronary artery bypass grafting (CABG).
- The subject has a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
- The subject has impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
- The subject has atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
- The subject has a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100 mm Hg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy for coronary artery stenosis detection at the per-segment, per-vessel and per-patient level using an 18-coronary artery segment model as defined by Society of Cardiovascular Computed Tomography (SCCT), as compared to ICA.
Time frame: 72 hours
1 secondary outcome
Heart rate increase and variability during contrast injection. Rates of 7-day contrast-induced nephropathy. Any untoward adverse reactions like flushing, itching, nausea/vomiting etc
Time frame: 7 days
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 11 Dec 2012.
- Background: PubMed 19038879Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
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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.
Robert Benton, MD principal investigator
Capital Cardiology Associates
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis, run by MDDX LLC at 3 sites in 2 countries.
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 5 inclusion and 11 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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.
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?
Diagnostic accuracy for coronary artery stenosis detection at the per-segment, per-vessel and per-patient level using an 18-coronary artery segment model as defined by Society of Cardiovascular Computed Tomography (SCCT), as compared to ICA. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052441, which also lists 1 linked publication.
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 11 Dec 2012.