Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography

The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors computed tomography (CORE-320) was designed as a prospective, multi-center, international, blinded study designed to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in patients with suspected coronary artery disease. The primary analysis will be a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the combination of conventional coronary angiography and SPECT myocardial perfusion imaging at the patient level. A positive patient will be defined as having at least one vessel with a ≥ 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect.

Inclusion criteria

• Male or female patients, age 45-85. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
• Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography; and planned coronary angiography within the next 60 days.
• Able to understand and willing to sign the Informed Consent Form.

Exclusion criteria

• Known allergy to iodinated contrast media.
• History of contrast-induced nephropathy.
• History of multiple myeloma or previous organ transplantation.
• Elevated serum creatinine (> 1.5 mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula.
• Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block).
• Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis.
• Previous coronary artery bypass or other cardiac surgery.
• Coronary artery intervention within the last 6 months.
• Known or suspected intolerance or contraindication to beta-blockers including:

• Known allergy to beta-blockers
• History of moderate to severe bronchospastic lung disease (including moderate to severe asthma).
• Severe pulmonary disease (chronic obstructive pulmonary disease).
• Presence of any other history or condition that the investigator feels would be problematic.
• SPECT preformed in non-validated center within 60 days prior to screening.
• SPECT performed within the previous 6 months of screening but > 60 days.
• SPECT studies performed within 60 days of screening that include rest and stress studies performed using 2 day protocols.
• BMI greater than 40