Cardiovascular DiseaseCAVIARNCT02971020
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
A study testing Observational/Cognitive Assessment in people with Cardiovascular Disease and Aortic Valve Stenosis, run by Minnesota Veterans Medical Research and Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 104 years
- Conditions the study is for
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments
- What is being tested?
- Observational/Cognitive Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 21 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 104 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
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.
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery, Transcatheter Valve Replacement, Surgical Valve Replacement
- Being tested
- Observational/Cognitive Assessment
- Medical subject headings
- Cardiovascular Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational/Cognitive AssessmentOther
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
| Study group | Role | What they receive |
|---|---|---|
| Surgical Aortic Valve Replacement | Other | Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). Receives: Other: Observational/Cognitive Assessment |
| Transcatheter Aortic Valve Replacement | Other | Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). Receives: Other: Observational/Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Months
Trail Making
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion12 Nov 2017
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Veterans Medical Research and Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Santiago Garcia, Minnesota Veterans Medical Research and Education Foundation
- Investigators
- Santiago Garcia, MD, Principal investigator, Minneapolis Veterans Affairs Medical CenterHoward Fink, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971020
- Sponsor's protocol ID
- 4588-A
- Acronym
- CAVIAR
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02971020
- Acronym / sponsor ID
- CAVIAR / 4588-A
- Conditions
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery, Transcatheter Valve Replacement, Surgical Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Minnesota Veterans Medical Research and Education FoundationUniversity, hospital or other
- Collaborators
- Minneapolis Veterans Affairs Medical Center
- Study start
- May 2016 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Aortic Valve Replacement | Other | Other: Observational/Cognitive AssessmentMontreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). |
| Transcatheter Aortic Valve Replacement | Other | Other: Observational/Cognitive AssessmentMontreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). |
Who may qualify
- Ages
- Up to 104 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational/Cognitive AssessmentMontreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). | Other | Surgical Aortic Valve Replacement, Transcatheter Aortic Valve Replacement |
Primary outcome
Montreal Cognitive Assessment
Time frame: Three Months
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
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Garcia, MD principal investigator
Minneapolis Veterans Affairs Medical Center
Howard Fink, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observational/Cognitive Assessment in people with Cardiovascular Disease and Aortic Valve Stenosis, run by Minnesota Veterans Medical Research and Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: Three Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.