Validation of the Siemens System Somatom Definition and Operating Software for Cardiac CT Studies (SOMARIS)
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|ClinicalTrials.gov Identifier: NCT00481468|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : September 27, 2012
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||385 participants|
|Official Title:||Validation of the Siemens System Somatom Definition and Operating Software SYNGO CT2007 (Software Version SOMARIS/7 SYNGO® Software) for Cardiac CT Studies|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||March 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481468
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Gilbert Raff, MD||William Beaumont Hospitals|