NCT00861653

Brief Summary

The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 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

Study Start

First participant enrolled

October 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

4.8 years

First QC Date

March 11, 2009

Last Update Submit

April 14, 2014

Conditions

Atherosclerosis

Keywords

AtherosclerosisSubjects diagnosed with atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis

    2 years post study initiation

Secondary Outcomes (1)

  • To evaluate the effectiveness of MR imaging in identifying these plaque characteristics

    2 Years Post Study Initiation

Eligibility Criteria

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

Subjects diagnosed with atherosclerosis

You may qualify if:

  • Age range \>17 years of age
  • Surgical carotid artery disease
  • Provide written informed consent and Authorization for Use/Disclosure of PHI

You may not qualify if:

  • History of carotid trauma
  • History of middle or large vessel vasculitis
  • Refusal to provide written informed consent and Authorization for
  • Use/Disclosure of PHI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and tissue samples are collected for markers of inflammation and gene chip analysis

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sarah Rinehart, MD

    Piedmont Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 13, 2009

Study Start

October 1, 2006

Primary Completion

August 1, 2011

Study Completion

July 1, 2013

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

US(1)