- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321476
Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis (Carotid)
September 4, 2013 updated by: Piedmont Healthcare
This study will use excess tissue from endoscopic or surgical procedures to examine the elements of plaque that are found in the carotid walls of patients who have a type of heart and blood vessel disease called atherosclerosis.
Tissue will be collected from patients undergoing carotid procedures as well as patients undergoing liver and/or intestinal biopsies.
This lab study will examine the different types of proteins that play a role in developing heart plaque.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing a carotid, liver, and/or intestinal biopsy
Description
Inclusion Criteria:
- Age ≥18 years
- Scheduled for a clinically indicated, standard-of-care carotid endarterectomy (CEA) OR scheduled for a clinically indicated, standard-of- care surgical, laparoscopic or endoscopic intestinal biopsy or excision OR scheduled for a clinically indicated, standard-of-care surgical, laparoscopic or endoscopic liver biopsy or partial resection/excision
- Ability and willingness to consent and Authorization for use of PHI
Exclusion Criteria:
- Age ≤18 years
- Inability or unwillingness to consent and Authorization for use of PHI
- FOR CAROTID PATIENTS - history of carotid trauma, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
- FOR CAROTID PATIENTS - history of middle- or large-vessel vasculitis, that is determined by the Principal Investigator to significantly have changed the carotid tissue structure
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 |
Measure Description |
Time Frame |
---|---|---|
Demonstrated Plaques
Time Frame: up to 30 months
|
Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.
|
up to 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Miller, MD, Piedmont Heart Institute/Piedmont Hospital
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 Registration Dates
First Submitted
March 14, 2011
First Submitted That Met QC Criteria
March 22, 2011
First Posted (Estimate)
March 23, 2011
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Carotid
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.
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