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Structural Stability of Carotid Plaque and Symptomatology

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ClinicalTrials.gov Identifier: NCT02476396
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of the research is to understand structural plaque abnormalities that make a carotid plaque unstable and brake off (embolize) which would help to predict and treat individuals who are likely to suffer not only classic episodic major strokes but also cognitive impairment.

Condition or disease Intervention/treatment
Carotid Stenosis Stroke Carotid Artery Plaque Transient Ischemic Attack Cerebrovascular Accident Carotid Artery Stenosis Procedure: Carotid Endarterectomy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Structural Stability of Carotid Plaque and Symptomatology
Study Start Date : April 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
patient-subject
Patients will be recruited from the population of patients scheduled to undergo carotid endarterectomy for established clinical indications. These indications include patients scheduled to have a carotid endarterectomy due to the presence of a high-grade atherosclerotic cervical internal carotid artery stenosis with or without clinical symptoms, following the ACAS or NASCET criteria (carotid artery stenosis of 60% or greater without clinical symptoms; stenosis 70% or greater with clinical symptoms).
Procedure: Carotid Endarterectomy

Carotid endarterectomy is a procedure to treat carotid artery disease. This disease occurs when fatty, waxy deposits build up in one of the carotid arteries. The carotid arteries are blood vessels located on each side of your neck (carotid arteries).

This buildup of plaques (atherosclerosis) may restrict blood flow to your brain. Removing plaques causing the narrowing in the artery can improve blood flow in your carotid artery and reduce your risk of stroke.

In carotid endarterectomy, you an anesthetic. Your surgeon makes an incision along the front of your neck, opens your carotid artery and removes the plaques that are clogging your artery. Your surgeon then repairs the artery with stitches or a patch made with a vein or artificial material (patch graft).

Source: Mayo Clinic

patient-control
The controls will be recruited by the patient-subjects. The investigators will ask their patient-subjects to speak to a spouse or family member to see if they are interested in participating. If they do have an interest they will contact the research team/study coordinator(s). In case, a spouse or a family member is accompanying the patient-subject, they will be recruited at the same time as the patient-subject.



Primary Outcome Measures :
  1. Atherosclerotic carotid plaque elasticity with strain measurement could be defined and linked to correlating disease presentation [ Time Frame: 5 years ]
    This aim will study the relationship of structural instability in the carotid plaques with histopathologic evidence for fissuring of the plaques that may represent a micro-emboli source. The determination of a structural defect causing abnormal strain measurements in a carotid atherosclerotic plaque will be important in understanding the pathophysiology of this disorder, as well as, addressing future treatment strategies, which could include preventing angiogenesis, thrombosis, or abnormal cholesterol deposit within the plaque. This outcome measure is a composite.


Secondary Outcome Measures :
  1. Atherosclerotic plaque strain are cause of microemboli [ Time Frame: 5 years ]
    In this aim we will preoperatively measure the structural stability of each plaque ultrasonically while simultaneously recording distally for the presence of microemboli over time within the carotid system. Statistical composite analysis will establish the structural instability signature that predicts ongoing subclinical microemboli.

  2. Atherosclerotic plaque strain and microemboli result in cognitive and MRI changes of significant microvascular injury to the brain and significant cognitive decline [ Time Frame: 5 years ]
    This aim will analyze increased elasticity strain within carotid plaques as measured preoperatively with ultrasound and correlate these parameters with cognition and with quantifiable measurements of white matter ischemic lesion volume and cerebral blood flow (CBF) using non-invasive method of MRI arterial spin labeling in a composite measurement.

  3. Peripheral biomarkers for microRNA and proteases will noninvasively identify a population who would most benefit from intensive preventive strategies [ Time Frame: 5 years ]
    This aim will analyze the mRNA (messenger RNA) and microRNA expression profiles of the blood and the excised plaque samples from patients with stable and ruptured carotid atherosclerotic plaques. The RNA analysis will be conducted with the microarrays as a composite measurement.


Biospecimen Retention:   Samples With DNA

Subjects and controls will have 2 tubes of blood drawn. DNA will be removed and may be saved for future testing. Some cells from the participant's blood may be kept alive and growing in the laboratory as a "cell line". Creating a cell line will allow the investigators to get more DNA for future research.

Subjects will have their carotid plaques removed via standard carotid endarterectomy. This surgical procedure is part of the standard clinical care.

Blood samples will be decoded and unidentifiable, kept in a secure freezer box (with a lock and key) and stored in chamber of 1 -800C freezer used only to store human blood and RNA samples.

Plaque specimens will be de-identified. Samples will be kept in a secure freezer box stored in a chamber with authorized access only.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the population of patients scheduled to undergo carotid endarterectomy for established clinical indications. These indications include patients scheduled to have a carotid endarterectomy due to the presence of a high-grade atherosclerotic cervical internal carotid artery stenosis with or without clinical symptoms, following the ACAS or NASCET criteria (carotid artery stenosis of 60% or greater without clinical symptoms; stenosis 70% or greater with clinical symptoms).
Criteria

Inclusion Criteria:

  • Patients undergoing carotid endarterectomy for established clinical criteria
  • Age > 18 years
  • Male or Female
  • English speaking
  • Patients must sign written informed consent form

Exclusion Criteria:

  • Previous history of carotid artery surgery (endovascular or open)
  • Previous cervical radiation
  • Patients not felt be suitable for carotid endarterectomy
  • Patients with impaired consent capacity
  • Prisoner status

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): NCT02476396


Contacts
Contact: Robert J Dempsey, MD 608-265-5967 dempsey@neurosurgery.wisc.edu
Contact: Stephanie M Wilbrand, PhD 608-265-9248 s.wilbrand@neurosurgery.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Robert J Dempsey, MD University of Wisconsin, Madison

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02476396     History of Changes
Other Study ID Numbers: 2015-0289
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ischemic Attack, Transient
Constriction, Pathologic
Stroke
Carotid Stenosis
Pathological Conditions, Anatomical
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Carotid Artery Diseases
Arterial Occlusive Diseases