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Atherosclerotic Plaque Characterization (APC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861653
First Posted: March 13, 2009
Last Update Posted: April 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Piedmont Healthcare
  Purpose
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.

Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis [ Time Frame: 2 years post study initiation ]

Secondary Outcome Measures:
  • To evaluate the effectiveness of MR imaging in identifying these plaque characteristics [ Time Frame: 2 Years Post Study Initiation ]

Biospecimen Retention:   Samples With DNA
Serum and tissue samples are collected for markers of inflammation and gene chip analysis

Enrollment: 50
Study Start Date: October 2006
Study Completion Date: July 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with atherosclerosis
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861653


Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Principal Investigator: Sarah Rinehart, MD Piedmont Healthcare
  More Information

Responsible Party: Sarah Rinehart, MD
ClinicalTrials.gov Identifier: NCT00861653     History of Changes
Other Study ID Numbers: P06-31
First Submitted: March 11, 2009
First Posted: March 13, 2009
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Piedmont Healthcare:
Atherosclerosis
Subjects diagnosed with atherosclerosis

Additional relevant MeSH terms:
Atherosclerosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical