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Assessing Neurocognition After Cerebrovascular Intervention

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ClinicalTrials.gov Identifier: NCT03344276
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander A. Khalessi MD MS FAANS, University of California, San Diego

Brief Summary:
Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can result in decreased blood flow to the brain. The investigators seek to assess this relationship prospectively through performing a battery of neurocognitive assessments, collection of serum markers of inflammation, and through neuroimaging at two points before intervention (2 months and 1 month before stenting) and at two points after intervention (1 month and 2 months after intervention). The goal is to provide prospective evidence to identify the extent to which carotid stenosis and hypoperfusion of the brain results in diminished neurocognitive performance, and see if serum biomarkers before and after stenting correlate with these findings.

Condition or disease Intervention/treatment Phase
Carotid Artery Diseases Neurocognitive Dysfunction Diagnostic Test: Neurocognitive Assessments Diagnostic Test: Measurements of inflammatory biomarkers Procedure: Carotid Artery Stenting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In this pilot study 20 patients, undergoing CAS for CS, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months) and at 2 time points after invention (1 month and 2 months). The two preoperative time points will serve as the control group and the two postoperative time points will serve as the intervention group.

Patients will serve as their own controls, classifying the study as a within-subjects design. Patients will also have venous blood drawn to ascertain the change in serum markers associated with endothelial dysfunction and inflammation before and after intervention. Finally, patients will have magnetic resonance imaging (MRA) one month before intervention and 2 months after intervention in order to assess changes in global cerebral blood flow.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Neurocognition After Cerebrovascular Intervention
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Control Group
Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months). The two preoperative time points will serve as the control group.
Diagnostic Test: Neurocognitive Assessments
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. Prior to surgery patients will undergo a battery of neurocogntive assessments 1 month and 2 months prior to surgery.

Diagnostic Test: Measurements of inflammatory biomarkers
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers.

Experimental: Intervention Group
Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points after invention (1 month and 2 months). The two postoperative time points will serve as the intervention group.
Diagnostic Test: Neurocognitive Assessments
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. Prior to surgery patients will undergo a battery of neurocogntive assessments 1 month and 2 months prior to surgery.

Diagnostic Test: Measurements of inflammatory biomarkers
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers.

Procedure: Carotid Artery Stenting
Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.




Primary Outcome Measures :
  1. Neurocognition [ Time Frame: 4 months ]
    Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.


Secondary Outcome Measures :
  1. TNF-α [ Time Frame: 4 months ]
    Inflammatory Markers: tumor necrosis factor-α

  2. IL-6 [ Time Frame: 4 months ]
    Inflammatory Markers: IL-6

  3. IL-1β [ Time Frame: 4 months ]
    Inflammatory Markers: IL-1β

  4. CRP [ Time Frame: 4 months ]
    Inflammatory Markers: CRP

  5. IFN-γ [ Time Frame: 4 months ]
    Inflammatory Markers: IFN-γ

  6. sICAM-1 [ Time Frame: 4 months ]
    Inflammatory Markers: sICAM-1

  7. sVCAM-1 [ Time Frame: 4 months ]
    Inflammatory Markers: sVCAM-1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients >18 years of age
  • ultrasound evidence of carotid stenosis; in which the patient has either 50% or greater symptomatic carotid stenosis or 70% or greater asymptomatic carotid stenosis.

Exclusion Criteria:

  1. patients <18 years of age
  2. patients with without compatibility for MRI
  3. patients requiring carotid stenting for reasons not related to long-standing stenosis
  4. patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
  5. Patients that do not have appropriate capacity (i.e. understand the risks and benefits associated with this study) or are unable to consent for themselves will not be included in this study.

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): NCT03344276


Contacts
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Contact: Alexander Khalessi, MD (619) 543-5540 akhalessi@ucsd.edu
Contact: ARVIN WALI, BA, MAS 7149282722 AWALI@UCSD.EDU

Locations
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United States, California
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: David R Santiago-Dieppa, MD    619-543-5078    drsantiagodieppa@ucsd.edu   
Sub-Investigator: David R Santiago-Dieppa, MD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Alexander A Khalessi, MD UC San Diego
Study Director: David R Santiago-Dieppa, MD UC San Diego

Publications:

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Responsible Party: Alexander A. Khalessi MD MS FAANS, Acting Clinical Chief UCSD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03344276     History of Changes
Other Study ID Numbers: 170103
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Per institutional review board, data will only be shared with the researchers specified on the research protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Alexander A. Khalessi MD MS FAANS, University of California, San Diego:
carotid stenosis
neurocognition
carotid stenting
circle of willis

Additional relevant MeSH terms:
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Carotid Artery Diseases
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders