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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Mild Cognitive Impairment Undergoing TAVR | Patients will be treated with standard of care. In addition, patients will complete the mini MoCA at 3 time points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 minute Montreal Cognitive Assessment (mini MoCA) | Other | The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognition measured by Mini MoCA at 30 days post TAVR | Changes in neurocognition compared to baseline at 30 days | 30 days post TAVR |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognition measured by Mini MoCA at 6 months post TAVR | Changes in neurocognition compared to baseline at 6 months | 6 months post TAVR |
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Inclusion Criteria:
Age 18 years or older
Undergoing a TAVR procedure
Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 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.
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Patients undergoing TAVR with mild cognitive impairment
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| Name | Affiliation | Role |
|---|---|---|
| Srinivasa Potluri, MD | Baylor Scott and White The Heart Hospital Plano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | United States | ||
| Baylor Scott & White All Saints at Fort Worth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27692728 | Result | 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. | |
| 33213758 |
| Label | URL |
|---|---|
| MoCA Cognitive Assessment | View source |
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IPD will not be shared with other researchers
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| Fort Worth |
| Texas |
| 76104 |
| United States |
| Baylor Scott and White The Heart Hospital Baylor Plano | Plano | Texas | 75029 | United States |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Result |
| 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. |
| 25740785 | Result | Arevalo-Rodriguez I, Smailagic N, Roque 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 cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2. |
| 18625866 | Result | 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. |
| 15817019 | Result | Nasreddine ZS, Phillips NA, Bedirian 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. doi: 10.1111/j.1532-5415.2005.53221.x. |
| 29159840 | Result | 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. |
| 30910550 | Result | 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. |
| 25700290 | Result | 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(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19. |
| 27071646 | Result | 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 neurodegenerative disease. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1303-1310. doi: 10.1136/jnnp-2015-312723. Epub 2016 Apr 12. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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