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

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
MDDX LLC
ClinicalTrials.gov Identifier:
NCT01052441
First received: January 14, 2010
Last updated: December 8, 2012
Last verified: December 2012
  Purpose

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
Coronary Arteriosclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Iodine Content for Diagnostic AccuRacy and Patient Comfort For Individuals Undergoing Cardiac CT Scanning: The Multicenter ICARUS Trial

Resource links provided by NLM:


Further study details as provided by MDDX LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052441

Locations
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
MDDX LLC
GE Healthcare
Investigators
Principal Investigator: Robert Benton, MD Capital Cardiology Associates
  More Information

Publications:
Miller JM, Rochitte CE, Dewey M, et al. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med 2008; 359:2324-2336.

Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT01052441     History of Changes
Other Study ID Numbers: GEH-CRLLC-1.2009
Study First Received: January 14, 2010
Last Updated: December 8, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014