Assessing Neurocognition After Cerebrovascular Intervention

NCT03344276 | Recruiting DMC FDA Device

• 1 other identifier: 170103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases; Neurocognitive Dysfunction

Keywords

carotid stenosis; neurocognition; carotid stenting; circle of willis

Outcome Measures

Primary Outcomes (1)

• Neurocognition

  Neurocognition will be assessed through a battery of 8 tests to measure cognitive capacity across a range of neurocognitive domains.

  4 months

Secondary Outcomes (7)

• TNF-α

  4 months

• IL-6

  4 months

• IL-1β

  4 months

• CRP

  4 months

• IFN-γ

  4 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Diagnostic Test: Measurements of inflammatory biomarkers

Intervention Group

EXPERIMENTAL

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; Diagnostic Test: Measurements of inflammatory biomarkers; Procedure: Carotid Artery Stenting

Interventions

Neurocognitive Assessments DIAGNOSTIC_TEST

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.

Control Group; Intervention Group

Measurements of inflammatory biomarkers DIAGNOSTIC_TEST

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

Control Group; Intervention Group

Carotid Artery Stenting PROCEDURE

Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients \<18 years of age
• patients with without compatibility for MRI
• patients requiring carotid stenting for reasons not related to long-standing stenosis
• patients requiring emergency carotid stenting for acute symptoms such as crescendo transient ischemic attacks, intolerance of physiologic blood pressure.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

RECRUITING

Related Publications (8)

• Arntzen KA, Schirmer H, Johnsen SH, Wilsgaard T, Mathiesen EB. Carotid atherosclerosis predicts lower cognitive test results: a 7-year follow-up study of 4,371 stroke-free subjects - the Tromso study. Cerebrovasc Dis. 2012;33(2):159-65. doi: 10.1159/000334182. Epub 2012 Jan 5.

  PMID: 22222422 BACKGROUND

• Baracchini C, Mazzalai F, Gruppo M, Lorenzetti R, Ermani M, Ballotta E. Carotid endarterectomy protects elderly patients from cognitive decline: a prospective study. Surgery. 2012 Jan;151(1):99-106. doi: 10.1016/j.surg.2011.06.031. Epub 2011 Sep 22.

  PMID: 21943640 BACKGROUND

• Shapiro AM, Benedict RH, Schretlen D, Brandt J. Construct and concurrent validity of the Hopkins Verbal Learning Test-revised. Clin Neuropsychol. 1999 Aug;13(3):348-58. doi: 10.1076/clin.13.3.348.1749.

  PMID: 10726605 BACKGROUND

• Blake GJ, Ridker PM. Novel clinical markers of vascular wall inflammation. Circ Res. 2001 Oct 26;89(9):763-71. doi: 10.1161/hh2101.099270.

  PMID: 11679405 BACKGROUND

• Cheng Y, Wang YJ, Yan JC, Zhou R, Zhou HD. Effects of carotid artery stenting on cognitive function in patients with mild cognitive impairment and carotid stenosis. Exp Ther Med. 2013 Apr;5(4):1019-1024. doi: 10.3892/etm.2013.954. Epub 2013 Feb 8.

  PMID: 23596467 BACKGROUND

• North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.

  PMID: 1852179 BACKGROUND

• Wendell CR, Waldstein SR, Ferrucci L, O'Brien RJ, Strait JB, Zonderman AB. Carotid atherosclerosis and prospective risk of dementia. Stroke. 2012 Dec;43(12):3319-24. doi: 10.1161/STROKEAHA.112.672527. Epub 2012 Oct 25.

  PMID: 23103489 BACKGROUND

• Sun Q, Xia Z, Qu C, Ruan X, Li J, Cong L, Zheng X, Du Y. Carotid artery stenting ameliorates the cognitive impairment in patients with leukoaraiosis, the ischemic change of cerebral white matter. Tohoku J Exp Med. 2014 Aug;233(4):257-64. doi: 10.1620/tjem.233.257.

  PMID: 25098321 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases; Cognition Disorders; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Arterial Occlusive Diseases

Study Officials

• Alexander A Khalessi, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

• David R Santiago-Dieppa, MD

  UC San Diego

  STUDY DIRECTOR

Central Study Contacts

Alexander Khalessi, MD

CONTACT

(619) 543-5540; akhalessi@ucsd.edu

ARVIN WALI, BA, MAS

CONTACT

7149282722; AWALI@UCSD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Clinical Chief UCSD

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: July 15, 2021
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)