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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Markus Meyer, MD
- Número de teléfono: 802-922-0656
- Correo electrónico: markusmeyermd@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Samantha Wansing
- Correo electrónico: hoppx054@umn.edu
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Medical Center
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Contacto:
- Markus Meyer, MD
- Número de teléfono: 612-625-9538
- Correo electrónico: meye3249@umn.edu
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Investigador principal:
- Markus Meyer, MD
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Minneapolis, Minnesota, Estados Unidos, 55455
- M Health Fairview Clinics and Surgery Center
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Contacto:
- Samantha Wansing
- Correo electrónico: hoppx054@umn.edu
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Contacto:
- Markus Meyer, MD
- Número de teléfono: 612-625-9538
- Correo electrónico: meye3249@umn.edu
-
Investigador principal:
- Markus Meyer, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
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Experimental: 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.
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Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Montreal Cognitive Assessment Total Score
Periodo de tiempo: Baseline to 3 months after pacemaker implantation
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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.
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Baseline to 3 months after pacemaker implantation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Short Form 36 Health Survey Mental Component Summary Score
Periodo de tiempo: Baseline to 3 months after pacemaker implantation
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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.
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Baseline to 3 months after pacemaker implantation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Selma Carlson, MD, University of Minnesota
- Investigador principal: Markus Meyer, MD, University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CV-2026-34972
- STUDY00028711 (Otro identificador: University Of Minnesota)
Información sobre medicamentos y dispositivos, documentos del estudio
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