Validation of the Siemens System Somatom Definition and Operating Software for Cardiac CT Studies

We will obtain and read CT coronary angiograms (CAT scans of the heart arteries) with the assistance of the new imaging software analysis package. Analysis of technical and clinical data will be recorded on the case report forms. This will be an observational design. We intend to test the results of our analyses through a Test Plan looking at Cardio functionality (hardware and software), System performance (reconstruction, loading, transferring, archiving),and System stability.

We plan to find out the relevant effect of our clinical reading results by enrolling our patients in a long-term clinical outcomes database. To evaluate the presence of traditional coronary risk factors, a focused medical history will be requested (see attached) as well as access to relevant medical records to determine the presence of major adverse cardiac events. These will be handled in a confidential manner and will be de-identified using subject number and initial only to be compliant with HIPAA.

Inclusion criteria

• Ability to provide informed consent
• Age equal to or greater than 18 years -

Exclusion criteria

• Renal (kidney) insufficiency (creatinine greater than or equal to 1.6) or renal (kidney) failure requiring dialysis.
• Atrial fibrillation (type of heart rhythm) or other markedly irregular rhythm.
• Inability or refusal to provide informed consent.
• Psychological unsuitability or extreme claustrophobia (fear of closed in spaces).
• Pregnancy or unknown pregnancy status.
• Age less than 18 years.
• Clinical instability as deemed by the attending physician, including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), refractory hypertension (high blood pressure) (systolic blood pressure greater than 180 mmHg), sustained ventricular or atrial arrhythmia (types of heart rhythm) requiring intravenous medications.
• Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease (temporary narrowing of the tubes in the lungs) (or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block (chambers in the heart not beating in sync), second-degree atrioventricular block (chambers in the heart not beating in sync).
• Known contrast dye allergy.