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NCT01321476 Clinical Trial

Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

Heart Disease Clinical Trial

— Carotid  

Official title:
Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01321476
Other study ID # Carotid
Secondary ID
Status Withdrawn
Phase N/A
First received March 14, 2011
Last updated September 4, 2013

Study information
Verified date July 2011
Source Piedmont Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Piedmont Healthcare Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Demonstrated Plaques Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques. up to 30 months No
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