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

NCT01052441 | Completed

• 1 other identifier: GEH-CRLLC-1.2009
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 3

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.

Conditions

Coronary Arteriosclerosis

Keywords

CCTA; Coronary Artery Stenosis; Iodinated Contrast; Invasive Coronary Angiography

Outcome Measures

Primary Outcomes (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.

  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

  7 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MDDX LLC: lead
• GE Healthcare: collaborator

Study Sites (3)

Capital Cardiology Associates

Albany, New York, 12211, United States

Location

Hudson Valley Heart Center

Poughkeepsie, New York, 12601, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

• 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.

  PMID: 19038879 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Benton, MD

  Capital Cardiology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (2); CA (1)