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