Arterial Occlusive Diseases, Arteriosclerosis, Coronary Artery Disease, Coronary Disease, Heart Diseases, Ischemia, Myocardial Ischemia, Vascular Diseases
Conditions
Keywords
Coronary Artery Disease, Computed Tomography, Myoperfusion, Angiography, SPECT
Brief summary
The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.
Detailed description
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.
Interventions
PROCEDURE320 Volume Detector Computed Tomography
Single Arm Study. All patients undergo Volume (Multidetector) CT.
OTHEROther: Multidetector Computed Tomography - 320 detectors
Multidetector computed tomography angiography
Sponsors
Toshiba America Medical Systems, Inc.
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease. | 30-60 Days | Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in a patient with suspected coronary artery disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of volume computed tomography using 320 detectors in a vessel of a patient with suspected coronary artery disease. | 30-60 Days | Diagnostic accuracy of volume computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding territorial myocardium perfusion defects in a vessel of a patient with suspected coronary artery disease. |
| Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA | 30-60 Days | Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA |
| Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography. | 30-60 Days | Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography. |
Countries
Brazil, Canada, Denmark, Germany, Japan, Netherlands, Singapore, United States
Outcome results
None listed