Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

Mild Cognitive Impairment Clinical Trial

— Neurcog TAVR  

Official title:

Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement: Periprocedural Changes and Predictors of Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614986
• Other study ID #: 021-262
• Status: Recruiting
• Start date: January 17, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2022
• Source: Baylor Research Institute
• Contact: Sarah Hale
• Phone: 469-814-4845
• Email: sarah.hale[@]bswhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• 5 minute Montreal Cognitive Assessment (mini MoCA)
The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR

Locations

Country	Name	City	State
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Baylor Scott & White All Saints at Fort Worth	Fort Worth	Texas
United States	Baylor Scott and White The Heart Hospital Baylor Plano	Plano	Texas
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

Arevalo-Rodriguez I, Smailagic N, Roqué I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cogni — View Citation

Auffret V, Campelo-Parada F, Regueiro A, Del Trigo M, Chiche O, Chamandi C, Allende R, Cordoba-Soriano JG, Paradis JM, De Larochellière R, Doyle D, Dumont E, Mohammadi S, Côté M, Marrero A, Puri R, Rodés-Cabau J. Serial Changes in Cognitive Function Follo — View Citation

Khan MM, Herrmann N, Gallagher D, Gandell D, Fremes SE, Wijeysundera HC, Radhakrishnan S, Sun YR, Lanctôt KL. Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis. J Am Geriatr Soc. 2018 Feb;66(2):254-262. doi: 10.1111/jgs.1512 — View Citation

Liew TM. The Optimal Short Version of Montreal Cognitive Assessment in Diagnosing Mild Cognitive Impairment and Dementia. J Am Med Dir Assoc. 2019 Aug;20(8):1055.e1-1055.e8. doi: 10.1016/j.jamda.2019.02.004. Epub 2019 Mar 23. — View Citation

Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am — View Citation

O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963. — View 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. do — View Citation

Roalf DR, Moore TM, Wolk DA, Arnold SE, Mechanic-Hamilton D, Rick J, Kabadi S, Ruparel K, Chen-Plotkin AS, Chahine LM, Dahodwala NA, Duda JE, Weintraub DA, Moberg PJ. Defining and validating a short form Montreal Cognitive Assessment (s-MoCA) for use in n — View Citation

Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognition measured by Mini MoCA at 30 days post TAVR	Changes in neurocognition compared to baseline at 30 days	30 days post TAVR
Secondary	Neurocognition measured by Mini MoCA at 6 months post TAVR	Changes in neurocognition compared to baseline at 6 months	6 months post TAVR

External Links

•   MoCA Cognitive Assessment