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

Completed

Conditions studied: Coronary Arteriosclerosis

In brief

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.

Key facts

Study ID

NCT01052441

Run by

MDDX LLC

People needed

250

Starts

2010-01-01

Expected to finish

2012-09-01

Last updated by the study team

2012-12-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Capital Cardiology Associates — Albany, New York, United States
• Hudson Valley Heart Center — Poughkeepsie, New York, United States
• University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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