NCT01879397

Brief Summary

Pilot prospective two group observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

6.8 years

First QC Date

June 13, 2013

Last Update Submit

July 13, 2020

Conditions

Atherosclerosis

Keywords

atherosclerosisarteriosclerosiscarotid stenosiscarotid endarterectomyStroke

Outcome Measures

Primary Outcomes (1)

  • Classification Algorithm Error Rate

    Classification of carotid artery plaque is produced by an algorithm that uses the QUS and ARFI derived parameters corresponding to a given region in the plaque to produce a classification of the plaque region into one of the following: calcium, fibrous, necrotic, or hemorrhagic. Error rates from both the training and test data sets will be reported.

    Baseline

Study Arms (2)

CEA Group

Subjects with atherosclerotic stenosis of the carotid artery and are scheduled for a clinically indicated Carotid Endarterectomy (CEA) procedure to remove the atherosclerotic plaque. Prior to CEA procedure, a research ultrasound exam will be performed. The plaque tissue removed during the CEA will be collected and processed into histological slides.

Device: Research Ultrasound Exam

Normal Group

Subjects who are not scheduled for a Carotid Endarterectomy (CEA) procedure and have had no prior carotid artery interventions. Subjects will have a Research Ultrasound Exam performed.

Device: Research Ultrasound Exam

Interventions

Research Ultrasound ExamDEVICE

Collection of backscattered ultrasound data during non-invasive ultrasound exam * ARFI based images of the carotid artery and plaque * Ultrasound signals received by the ultrasound imaging system are recorded. These signals are discarded during the image formation process for a standard duplex ultrasound exam.

CEA GroupNormal Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People 40 years old or older who are scheduled for a CEA for atherosclerotic plaque removal within the carotid artery will be considered for enrollement in the CEA Cohort (anticipated enrollment of 50). A small number of people 40 years old or older with no CEA scheduled and no prior carotid intervention will be enrolled into the Normal Cohort (anticipated enrollment of 5).

You may qualify if:

  • Age ≥40years
  • Scheduled to undergo CEA for clinically significant carotid stenosis
  • CEA is being performed for carotid stenosis of one or more of the following vessels: Internal Carotid Artery (ICA), distal end of the Common Carotid Artery (CCA), and/or CCA bulb.

You may not qualify if:

  • Pregnancy
  • Prior surgery or intervention involving the carotid artery
  • Prior stent in the carotid artery
  • Unable to provide informed consent
  • CEA for carotid stenosis for proximal CCA only (ICA and distal CCA are not involved)
  • CEA is scheduled for non-atherosclerotic vascular disease (e.g.,. fibromuscular dysplasia or systemic vasculitis)
  • Unable to understand English language.
  • Normal Cohort:
  • Age ≥40years
  • Pregnancy
  • Prior surgery or intervention involving the carotid artery (including CEA)
  • Prior stent in the carotid artery
  • Unable to provide informed consent
  • Unable to understand English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Carotid plaque removed during Carotid Endarterectomy (CEA) for subjects in the CEA Cohort will be collected and processed for production of histology slides.

MeSH Terms

Conditions

AtherosclerosisArteriosclerosisCarotid StenosisStroke

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • D. Geoffrey Vince, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department Chair

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 17, 2013

Study Start

May 1, 2013

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)