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

NCT00481468 | Completed DMC

• 1 other identifier: 2006-059
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Pain

Keywords

Coronary artery disease; chest pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This sutdy is taking place in a 900+ bed community setting hospital. All patients who meet the inclusion and exclusion criteria will be asked if they would like to participate when they arrive to the radiology department to undergo their cornary CT scan.

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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gilbert Raff, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Advanced Cardiovascular Imaging

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: March 1, 2010
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)