Cardiovascular Disease Clinical Trial
— CAVIAROfficial 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.
Verified date | March 2018 |
Source | Minnesota Veterans Medical Research and Education Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | March 21, 2018 |
Est. primary completion date | November 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 104 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Minneapolis VA Health Care System | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Minnesota Veterans Medical Research and Education Foundation | Minneapolis Veterans Affairs Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Three Months | |
Primary | Trail Making | 3 months |
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