NCT01928095

Brief Summary

The research objectives of this project are as follows:

  1. 1.Obtain high-quality human atherosclerotic arterial samples from diseased donors.
  2. 2.Perform biochemical analysis to determine the abundance, localization and activity of Dicer and double-stranded RNAs in these diseased tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3.1 years

First QC Date

August 20, 2013

Last Update Submit

April 11, 2017

Conditions

Atherosclerosis

Keywords

atherosclerosiscarotid endartherectomy

Outcome Measures

Primary Outcomes (1)

  • Altered Dicer Activity

    The investigator will measure the relative levels of abundant canonical Dicer substrates/enzymatic products (i.e. the ratio of pre- to mature micro-RNA) via northern blot

    1 year

Secondary Outcomes (1)

  • Are downstream mediators of Dicer dysregulation activated

    1 Year

Other Outcomes (1)

  • Dicer dysregulation displays cell type-specific patterns.

    1 year

Study Arms (1)

Carotid Endocardectomy Patients

Subsequent analyses will be performed on the basis of the pathological grading provided by UK Pathology (e.g do readouts of the Dicer pathway correlate with pathological plaque characteristics).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and Female patients undergoing carotid endarterectomy

You may qualify if:

  • Age of 18 and older
  • Undergoing carotid endarterectomy

You may not qualify if:

  • Under 18 years of age
  • Not undergoing carotid endarterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

discarded artherosclerotic tissue obtained during carotid endarterectomy

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bradley Gelfand, PhD

    University of Virginia, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

  • Bradley Gelfand, PhD

    Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 23, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)