Cognitive Function, Health Status, Pacemaker, Symptomatic Bradycardia
Conditions
Keywords
PACE Cognition, Symptomatic bradycardia, Physiologic pacing, Pacemaker programming, myPACE algorithm
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPhysiologic Pacemaker Programming
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
DEVICEStandard Pacemaker Programming
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
Sponsors
University of Minnesota
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants requiring permanent pacemaker implantation for bradycardia will be randomized to standard pacing 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 at the routine 3-month pacemaker clinic visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montreal Cognitive Assessment Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Form 36 Health Survey Mental Component Summary Score | 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. |
Countries
United States
Contacts
CONTACTMarkus Meyer, MD
CONTACTSamantha Wansing
PRINCIPAL_INVESTIGATORSelma Carlson, MD
University of Minnesota
PRINCIPAL_INVESTIGATORMarkus Meyer, MD
University of Minnesota
Outcome results
None listed