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WithdrawnNCT01321476CarotidUpdated Sep 5, 2013

Contribution of Hepatic and Intestinal Lipoproteins to Human Atherosclerosis

An observational study in Heart Disease, sponsored by Piedmont Healthcare. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by Piedmont Healthcare · Observational

Why this study was withdrawn
Study was never initiated and internal decision to discontinue initiation process
Study type
Observational
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Heart Disease
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

Browse Heart Diseases studies →

Lead sponsor

Piedmont Healthcare is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Demonstrated Plaques

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

    Time frame: up to 30 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01321476
Lead sponsor
Piedmont Healthcare
Collaborators
Merck Sharp & Dohme LLC
First posted
Mar 23, 2011
Last update
Sep 5, 2013

Study contacts

Joseph Miller, MD
principal investigator · Piedmont Heart Institute/Piedmont Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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