Chest PainSOMARISNCT00481468
Validation of the Siemens System Somatom Definition and Operating Software for Cardiac CT Studies
An observational study of Chest Pain, run by Corewell Health East at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Ability to provide informed consent
- Age equal to or greater than 18 years -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Validation of the Siemens System Somatom Definition and Operating Software SYNGO CT2007 (Software Version SOMARIS/7 SYNGO® Software) for Cardiac CT Studies
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.
Read the detailed 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.
- Conditions
- Chest Pain
- Keywords
- Coronary artery disease, chest pain
- Medical subject headings
- Chest Pain, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilbert L. Raff, MD, Corewell Health East
- Investigators
- Gilbert Raff, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481468
- Sponsor's protocol ID
- 2006-059
- Acronym
- SOMARIS
- Status last verified
- Sep 2012
- First submitted
- 30 May 2007
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Siemens System Somatom Definition and Operating Software SYNGO CT2007 (Software Version SOMARIS/7 SYNGO® Software) for Cardiac CT Studies
- ClinicalTrials.gov ID
- NCT00481468
- Acronym / sponsor ID
- SOMARIS / 2006-059
- Conditions
- Chest Pain
- Keywords
- Coronary artery disease, chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Ability to provide informed consent
- Age equal to or greater than 18 years -
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Raff, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.