Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis (Carotid)
This study has been withdrawn prior to enrollment.
(Study was never initiated and internal decision to discontinue initiation process)
Merck Sharp & Dohme Corp.
Information provided by:
First received: March 14, 2011
Last updated: September 4, 2013
Last verified: July 2011
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.
||Time Perspective: Prospective
||Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
Carotid artery tissue Liver biopsy tissue Intestinal biopsy tissue Cell cultures
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing a carotid, liver, and/or intestinal biopsy
- 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
- 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
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: NCT01321476
Merck Sharp & Dohme Corp.
||Joseph Miller, MD
||Piedmont Heart Institute/Piedmont Hospital
No publications provided
ClinicalTrials.gov processed this record on March 31, 2015
||Joseph Miller, MD, Piedmont Heart Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 14, 2011
||September 4, 2013
||United States: Institutional Review Board