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Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement (CAVIAR)

Primary Purpose

Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Observational/Cognitive Assessment
Sponsored by
Minnesota Veterans Medical Research and Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiovascular Disease

Eligibility Criteria

undefined - 104 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak velocity > 4 m/s)
  • Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System

Exclusion Criteria:

  • Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
  • Unable or unwilling to provide informed consent

Sites / Locations

  • Minneapolis VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Surgical Aortic Valve Replacement

Transcatheter Aortic Valve Replacement

Arm Description

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment
Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.
Trail Making

Secondary Outcome Measures

Full Information

First Posted
September 12, 2016
Last Updated
March 22, 2018
Sponsor
Minnesota Veterans Medical Research and Education Foundation
Collaborators
Minneapolis Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02971020
Brief Title
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
Acronym
CAVIAR
Official Title
Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
March 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minnesota Veterans Medical Research and Education Foundation
Collaborators
Minneapolis Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
Detailed Description
The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery, Transcatheter Valve Replacement, Surgical Valve Replacement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Aortic Valve Replacement
Arm Type
Other
Arm Description
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Arm Title
Transcatheter Aortic Valve Replacement
Arm Type
Other
Arm Description
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Intervention Type
Other
Intervention Name(s)
Observational/Cognitive Assessment
Intervention Description
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Description
Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.
Time Frame
Three Months
Title
Trail Making
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
104 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak velocity > 4 m/s) Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System Exclusion Criteria: Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures) Unable or unwilling to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Garcia, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard Fink, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement

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