PACE Cognition Proof-of-Concept Study
Impact of Physiologic Pacemaker Programming on Cognitive Function and Health Status in Patients With Symptomatic Bradycardia
This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.
Participants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit.
The primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Cardiac pacing may improve cognition by restoring physiologic heart rates, enhancing cerebral perfusion, and improving overall cardiovascular function in patients with symptomatic bradycardia who require permanent pacemaker implantation. In current clinical practice, the lower pacing rate is commonly programmed to 60 beats per minute, which is below the normal resting heart rate in many adults.
PACE Cognition is a proof-of-concept study evaluating the impact of physiologic pacemaker programming on cognitive function and health status. Patients requiring permanent pacemaker implantation for bradycardia will be screened before device implantation. Interested and eligible patients will provide written informed consent before any study-specific procedures are performed.
Baseline cognitive and health-status assessments will be completed before pacemaker implantation. Cognitive function will be assessed using the Montreal Cognitive Assessment, a brief standardized screening instrument that evaluates multiple cognitive domains, including memory, attention, language, visuospatial ability, executive function, and orientation. Health status and functional well-being will be assessed using the SF-36 questionnaire, including the mental component summary score.
Participants will be randomized to either standard pacing at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Follow-up Montreal Cognitive Assessment and SF-36 assessments will be repeated at the routine 3-month pacemaker clinic visit to evaluate changes in cognitive performance and health status between the pacing strategies.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Markus Meyer, MD
- Telefoonnummer: 802-922-0656
- E-mail: markusmeyermd@gmail.com
Studie Contact Back-up
- Naam: Samantha Wansing
- E-mail: hoppx054@umn.edu
Studie Locaties
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota Medical Center
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Contact:
- Markus Meyer, MD
- Telefoonnummer: 612-625-9538
- E-mail: meye3249@umn.edu
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Hoofdonderzoeker:
- Markus Meyer, MD
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Minneapolis, Minnesota, Verenigde Staten, 55455
- M Health Fairview Clinics and Surgery Center
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Contact:
- Samantha Wansing
- E-mail: hoppx054@umn.edu
-
Contact:
- Markus Meyer, MD
- Telefoonnummer: 612-625-9538
- E-mail: meye3249@umn.edu
-
Hoofdonderzoeker:
- Markus Meyer, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patient requiring a pacemaker for bradycardia
Exclusion Criteria:
- Vulnerable adult unable to give consent
- Unable to answer questionnaire
- Children
- Pregnant women/persons
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees or students of the researcher
- Active members of the military or DoD personnel
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Standard Pacemaker Programming
Participants randomized to this arm will receive standard pacemaker programming with a lower pacing rate of 60 beats per minute after permanent pacemaker implantation for bradycardia.
|
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
|
|
Experimenteel: Physiologic Pacemaker Programming
Participants randomized to this arm will receive individualized physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm after permanent pacemaker implantation for bradycardia.
|
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Montreal Cognitive Assessment Total Score
Tijdsspanne: Baseline to 3 months after pacemaker implantation
|
Change in Montreal Cognitive Assessment total score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm.
The Montreal Cognitive Assessment is scored from 0 to 30, with higher scores indicating better cognitive function.
|
Baseline to 3 months after pacemaker implantation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Short Form 36 Health Survey Mental Component Summary Score
Tijdsspanne: Baseline to 3 months after pacemaker implantation
|
Change in Short Form 36 Health Survey Mental Component Summary score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm.
The Short Form 36 Health Survey Mental Component Summary score ranges from 0 to 100, with higher scores indicating better mental health and psychological well-being.
|
Baseline to 3 months after pacemaker implantation
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Selma Carlson, MD, University of Minnesota
- Hoofdonderzoeker: Markus Meyer, MD, University of Minnesota
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CV-2026-34972
- STUDY00028711 (Andere identificatie: University Of Minnesota)
Informatie over medicijnen en apparaten, studiedocumenten
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