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Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging (CVMRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Buonocore, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00593541
First received: January 3, 2008
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Abnormalities, Cardiovascular

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve image quality by various techniques (e.g. reducing the effects of motion) [ Time Frame: Post-scanning ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 1999
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Noraml volunteers and patients with known or suspected cardiovascular disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593541

Sponsors and Collaborators
Michael Buonocore, MD, PhD
Investigators
Principal Investigator: Michael H Buonocore, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Michael Buonocore, MD, PhD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00593541     History of Changes
Other Study ID Numbers: 200210689
Study First Received: January 3, 2008
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
MRI

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013