Clinical trial NCT01052441: Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac Computed Tomography (CT) Scanning
Official title: Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac CT Scanning: The Multicenter ICARUS Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Keywords: CCTA
Coronary Artery Stenosis
Iodinated Contrast
Invasive Coronary Angiography
Lead sponsor: MDDX LLC
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2010-01-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
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.
timeFrame: 72 hours
Secondary outcomes:
measure: 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
timeFrame: 7 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Capital Cardiology Associates
name: Robert Benton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.