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A Multi-Center Study Combined Non-Invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography

Completed
Conditions
Coronary Stenoses
10011082
10007593
10003216
Registration Number
NL-OMON33255
Lead Sponsor
Toshiba Medical Systems
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
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

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 <60 ml/min;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 cardiac surgery;Coronary artery intervention within the last 6 months ;Known or suspected intolerance or contraindication to beta-blockers including;Severe pulmonary disease (chronic obstructive pulmonary disease)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary analysis will be a comparison of the diagnostic capability of the<br /><br>combination of quantitative 320-MDCT angiography and quantitative perfusion<br /><br>imaging to the combination of conventional coronary angiography and SPECT<br /><br>myocardial perfusion imaging at the patient level. A positive patient will be<br /><br>defined as having at least one vessel with a >= 50% diameter stenosis defined by<br /><br>quantitative coronary angiography and a corresponding positive SPECT<br /><br>territorial myocardial perfusion defect.</p><br>
Secondary Outcome Measures
NameTimeMethod
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