Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

NCT01321476 | Withdrawn

• 1 other identifier: Carotid
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (1)

• Demonstrated Plaques

  Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.

  up to 30 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a carotid, liver, and/or intestinal biopsy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead
• Merck Sharp & Dohme LLC: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Carotid artery tissue Liver biopsy tissue Intestinal biopsy tissue Cell cultures

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Joseph Miller, MD

  Piedmont Heart Institute/Piedmont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 23, 2011
• Last Updated: September 5, 2013

Record last verified: 2011-07