Assessment of Cognitive Function in Patients Undergoing C... | NCT00919165

Studies
Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

NCT00919165

Sponsor

Corewell Health West

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Cognitive Function in Carotid Stenting

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Mar 2017Actual

Completion Date

Apr 20, 2017Actual

First Submitted Date

Jun 11, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2023

Last Update Posted Date

Jul 13, 2023Actual

Name	Class
Abbott Medical Devices	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

Detailed Description

Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control and study group		severe carotid artery stenosis in asymptomatic patients defined as greater than 80% stenosis angiographically or greater than 400 cm/sec peak systolic velocity on carotid doppler evaluation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis		45 days

Secondary Outcomes

Measure	Description	Time Frame
to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting		45 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

40-80 years of age
Right hand dominate
Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
Baseline doppler study with a peak systolic velocity of 400cm/sec
Patient is deemed candidate for carotid artery stenting
TIMI flow of 1,2 or 3
80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
Subjects are able to give informed consent
Subjects are willing/able to complete follow-up visits

Exclusion Criteria:

History of major stroke: within the past 6 months
History of Alzheimers disease or Dementia
Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
Planned intervention opposite carotid artery within 2 months
Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
Any individual identified with cognitive impairment which would affect their performance during cognitive testing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with severe carotid artery stenosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Pastyrnak, PhD	Corewell Health West	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Spectrum Health		Grand Rapids	Michigan	49503	United States

Condition Browse Module

MeSH Terms

ID	Term
D016893	Carotid Stenosis

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided