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

Completed

Conditions studied: Chest Pain

In brief

We are evaluating a new computer software package to help us acquire and interpret heart CT studies, which is the purpose of this research project. We plan to compare the acquiring and analysis of heart artery calcium scores and CT angiograms (scans of the heart arteries) with the new SYNGO Somaris/7 Cardiac software to our previous experience with the the existing Siemens software and the TeraRecon software (current software used in the Cardiovascular MR/CT lab). The main objective of this study is to provide information to Siemens regarding the ease of use and capability of the scanner's software. The goal of this study is to determine whether the acquisition and interpretation information with the new software functionally meets the guidelines specified by Siemens, and also to determine whether the software is equivalent or superior to previous versions we used from April 2004 to April 2006.

Key facts

Study ID

NCT00481468

Run by

Corewell Health East

People needed

385

Starts

2006-06-01

Expected to finish

2010-03-01

Last updated by the study team

2012-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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