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

Chest Pain Clinical Trial

— SOMARIS  

Official title:

Validation of the Siemens System Somatom Definition and Operating Software SYNGO CT2007 (Software Version SOMARIS/7 SYNGO® Software) for Cardiac CT Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481468
• Other study ID #: 2006-059
• Status: Completed
• Phase: N/A
• First received: May 30, 2007
• Last updated: September 26, 2012
• Start date: June 2006
• Est. completion date: March 2010

Study information

• Verified date: September 2012
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: March 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to provide informed consent

2. Age equal to or greater than 18 years -

Exclusion Criteria:

1. Renal (kidney) insufficiency (creatinine greater than or equal to 1.6) or renal (kidney) failure requiring dialysis.

2. Atrial fibrillation (type of heart rhythm) or other markedly irregular rhythm.

3. Inability or refusal to provide informed consent.

4. Psychological unsuitability or extreme claustrophobia (fear of closed in spaces).

5. Pregnancy or unknown pregnancy status.

6. Age less than 18 years.

7. 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.

8. 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).

9. Known contrast dye allergy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States,