Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac Computed Tomography (CT) Scanning (ICARUS)

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. Identifier: NCT01052441
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : December 11, 2012
GE Healthcare
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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.

Condition or disease
Coronary Arteriosclerosis

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 Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac CT Scanning: The Multicenter ICARUS Trial
Study Start Date : January 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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 identifier (NCT number): NCT01052441

United States, New York
Capital Cardiology Associates
Albany, New York, United States, 12211
Hudson Valley Heart Center
Poughkeepsie, New York, United States, 12601
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Sponsors and Collaborators
GE Healthcare
Principal Investigator: Robert Benton, MD Capital Cardiology Associates

Responsible Party: MDDX LLC Identifier: NCT01052441     History of Changes
Other Study ID Numbers: GEH-CRLLC-1.2009
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by MDDX LLC:
Coronary Artery Stenosis
Iodinated Contrast
Invasive Coronary Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases