Clinical trial NCT05614986: Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement
Official title: Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement: Periprocedural Changes and Predictors of Improvement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Aortic Stenosis
Keywords: TAVR
Transcatheter Aortic Valve Replacement
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing TAVR with mild cognitive impairment

Brief summary: This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments.

Detailed description: Patients with mild cognitive impairment who are being treated with a TAVR can choose to take part in this trial. This trial will prospectively enroll patients at 4 Baylor Scott \& White facilities. 80 patients will be enrolled between all sites. The mini MoCA will be conducted at the following time points: pre TAVR, 30 days post TAVR, and 6 months post TAVR. All other data will be collected from patient charts and are considered standard part of their care.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Undergoing a TAVR procedure
3. Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:

   1. MMSE \< 27
   2. History of MCI, dementia, or stroke (CVA or TIA)
   3. History of prescription treatment for MCI
   4. Discretion of the investigator, physician, or clinic staff
4. Scores 25 or less on the mini MoCA exam

Exclusion Criteria:

1. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Primary outcomes:
measure: Neurocognition measured by Mini MoCA at 30 days post TAVR
timeFrame: 30 days post TAVR
Secondary outcomes:
measure: Neurocognition measured by Mini MoCA at 6 months post TAVR
timeFrame: 6 months post TAVR
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints at Fort Worth
state: Texas
city: Plano
country: United States
facility: Baylor Scott and White The Heart Hospital Baylor Plano
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
Study officials:
affiliation: Baylor Scott and White The Heart Hospital Plano
name: Srinivasa Potluri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auffret V, Campelo-Parada F, Regueiro A, Del Trigo M, Chiche O, Chamandi C, Allende R, Cordoba-Soriano JG, Paradis JM, De Larochelliere R, Doyle D, Dumont E, Mohammadi S, Cote M, Marrero A, Puri R, Rodes-Cabau J. Serial Changes in Cognitive Function Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Nov 15;68(20):2129-2141. doi: 10.1016/j.jacc.2016.08.046. Epub 2016 Sep 28.
citation: Potluri S, Szerlip M, Al-Azizi K, Harrington K, Kodali S, Kapadia S, Lu M, Leon MB, Mack MJ. Neurocognitive Function Change in Low-Risk Patients Undergoing TAVR Versus SAVR: Insights From PARTNER-3. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2713-2714. doi: 10.1016/j.jcin.2020.08.009. No abstract available.
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citation: Khan MM, Herrmann N, Gallagher D, Gandell D, Fremes SE, Wijeysundera HC, Radhakrishnan S, Sun YR, Lanctot KL. Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis. J Am Geriatr Soc. 2018 Feb;66(2):254-262. doi: 10.1111/jgs.15123. Epub 2017 Nov 21.
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