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Atherosclerotic Plaque Characterization (APC)

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ClinicalTrials.gov Identifier: NCT00861653
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : April 15, 2014
Sponsor:
Information provided by:
Piedmont Healthcare

Brief Summary:
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 or disease
Atherosclerosis

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging
Study Start Date : October 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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


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

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

Responsible Party: Sarah Rinehart, MD
ClinicalTrials.gov Identifier: NCT00861653     History of Changes
Other Study ID Numbers: P06-31
First Posted: March 13, 2009    Key Record Dates
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