- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593541
Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging (CVMRI)
May 24, 2017 updated by: University of California, Davis
This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.
Study Overview
Status
Terminated
Conditions
Detailed Description
This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities.
This Protocol is not restricted to imaging of a particular organ system or disease.
The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure.
It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.
Study Type
Observational
Enrollment (Actual)
42
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Noraml volunteers and patients with known or suspected cardiovascular disease
Description
Inclusion Criteria:
- 18 years of age or older
- Ability to give informed, written consent
- Not Pregnant or breastfeeding
Exclusion Criteria:
- Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
- Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
- History of uncontrolled claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images
Time Frame: Post-scanning
|
Post-scanning
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improve image quality by various techniques (e.g. reducing the effects of motion)
Time Frame: Post-scanning
|
Post-scanning
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael H Buonocore, MD, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 1999
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 3, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200210689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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