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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321476
First Posted: March 23, 2011
Last Update Posted: September 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Piedmont Healthcare
  Purpose
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.

Condition
Heart Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Demonstrated Plaques [ Time Frame: up to 30 months ]
    Presence of both liver and intestinally derived lipoprotein particles demonstrated in human atherosclerotic plaques.


Biospecimen Retention:   Samples With DNA
Carotid artery tissue Liver biopsy tissue Intestinal biopsy tissue Cell cultures

Enrollment: 0
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing a carotid, liver, and/or intestinal biopsy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321476


Sponsors and Collaborators
Piedmont Healthcare
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Joseph Miller, MD Piedmont Heart Institute/Piedmont Hospital
  More Information

Responsible Party: Joseph Miller, MD, Piedmont Heart Institute
ClinicalTrials.gov Identifier: NCT01321476     History of Changes
Other Study ID Numbers: Carotid
First Submitted: March 14, 2011
First Posted: March 23, 2011
Last Update Posted: September 5, 2013
Last Verified: July 2011

Additional relevant MeSH terms:
Heart Diseases
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases