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NCT00861653 Clinical Trial

Atherosclerotic Plaque Characterization

Atherosclerosis Clinical Trial

— APC  

Official title:
Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00861653
Other study ID # P06-31
Secondary ID
Status Completed
Phase N/A
First received March 11, 2009
Last updated April 14, 2014
Start date October 2006
Est. completion date July 2013

Study information
Verified date April 2014
Source Piedmont Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2013
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Piedmont Hospital Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Piedmont Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis 2 years post study initiation No
Secondary To evaluate the effectiveness of MR imaging in identifying these plaque characteristics 2 Years Post Study Initiation No
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