Coronary Stenoses
Conditions
Interventions
None listed
Sponsors
Toshiba Medical Systems
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female patients, age 45-85. ;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
Exclusion criteria: Known allergy to iodinated contrast media;History of contrast-induced nephropathy;History of multiple myeloma or previous organ transplantation;Elevated serum creatinine OR calculated creatinine clearance of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary analysis will be performed at the vessel level. Similar to the primary analysis, a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion data to the combination of conventional coronary angiography and SPECT myocardial perfusion data will be performed. A positive vessel will be defined as having at a >= 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect. Each patient will contribute three vessels to the analysis. Moreover we will also perform a patient based analysis to determine the diagnostic capability of the combination of quantitative 320-MDCT angiography and perfusion imaging to predict subsequent coronary revascularization. Additionally, we will compare the diagnostic capability of serum biomarkers independently and in conjunction with MDCT imaging to predict coronary revascularization and cardiovascular events (myocardial infarction, stroke, death). Lastly, we will perform a survival analysis comparing MDCT imaging with quantitative conventional coronary angiography. | — |
Countries
Netherlands
Outcome results
None listed