Atherosclerotic Plaque Characterization (APC)

This study has been completed.
Sponsor:
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT00861653
First received: March 11, 2009
Last updated: April 14, 2014
Last verified: April 2014

March 11, 2009
April 14, 2014
October 2006
August 2011   (final data collection date for primary outcome measure)
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis [ Time Frame: 2 years post study initiation ] [ Designated as safety issue: No ]
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00861653 on ClinicalTrials.gov Archive Site
To evaluate the effectiveness of MR imaging in identifying these plaque characteristics [ Time Frame: 2 Years Post Study Initiation ] [ Designated as safety issue: No ]
To evaluate the effectiveness of MR imaging in identifying these plaque characteristics [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Atherosclerotic Plaque Characterization
Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging

The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum and tissue samples are collected for markers of inflammation and gene chip analysis

Non-Probability Sample

Subjects diagnosed with atherosclerosis

Atherosclerosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2013
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age range >17 years of age
  • Surgical carotid artery disease
  • Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

  • History of carotid trauma
  • History of middle or large vessel vasculitis
  • Refusal to provide written informed consent and Authorization for
  • Use/Disclosure of PHI
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00861653
P06-31
No
Sarah Rinehart, MD
Piedmont Healthcare
Not Provided
Principal Investigator: Sarah Rinehart, MD Piedmont Healthcare
Piedmont Healthcare
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP