Atherosclerotic Plaque Characterization (APC)
April 14, 2014 updated by: Piedmont Healthcare
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects diagnosed with atherosclerosis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis
Time Frame: 2 years post study initiation
|
2 years post study initiation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the effectiveness of MR imaging in identifying these plaque characteristics
Time Frame: 2 Years Post Study Initiation
|
2 Years Post Study Initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
March 11, 2009
First Submitted That Met QC Criteria
March 12, 2009
First Posted (Estimate)
March 13, 2009
Study Record Updates
Last Update Posted (Estimate)
April 15, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.