Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effectiveness of MR imaging in identifying these plaque characteristics [ Time Frame: 2 Years Post Study Initiation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sarah Rinehart, MD
ClinicalTrials.gov Identifier: NCT00861653     History of Changes
Other Study ID Numbers: P06-31
Study First Received: March 11, 2009
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
Atherosclerosis
Subjects diagnosed with atherosclerosis

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

ClinicalTrials.gov processed this record on November 25, 2014