We aim to assess the association between variability and irregularity in heart rate (as caused by permanent atrial fibrillation), and cognitive function. In addition, variability and irregularity of the peripheral blood pressure will be correlated…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Structural brain disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive functioning at baseline and cognitive decline at two year follow up
measured with neuropsychological assessment.
Secondary outcome
Heart rate variability and irregularity
Peripheral blood pressure variation
Structural brain abnormalities
Risk factors
Background summary
Atrial fibrillation is a growing public health problem, reaching epidemic
proportions. There is also growing evidence that AF is independently associated
with cognitive impairment and dementia. Mechanisms are still largely unknown,
but hemodynamic instability and effects on cerebral perfusion have been
reported. It is important to clarify the hemodynamic and vascular contribution
of AF to vascular cognitive impairment (VCI) and increase the awareness of
cardiologists for the heart brain connection. This study will be part of the
Heart-Brain connection Crossroads (HCBx) project. One of the aims of this
project is to further unravel the roll of hemodynamic instability and the
development of VCI.
More research is necessary to more precisely establish the relation between
hemodynamic abnormalities in permanent atrial fibrillation, possibly mediated
through altered brain structure and perfusion, and vascular cognitive
impairment.
Study objective
We aim to assess the association between variability and irregularity in heart
rate (as caused by permanent atrial fibrillation), and cognitive function.
In addition, variability and irregularity of the peripheral blood pressure will
be correlated to heart rhythm, as well as cognitive function. To correlate
anatomical changes (e.g. emboli, brain laesions) to cognitive decline, a brain
MRI is performed.
Study design
Prospective observational cohort study with a follow up period of two years.
All subjects will undergo the same standardized set of clinical,
neuropsychiatric and imaging tests to assess cardiovascular risk factors and
disease, structural and functional brain and cardiac status, cognitive
dysfunction, daily functioning and presence of neuropsychiatric symptoms. After
two years assessment of daily functioning and neuropsychiatric symptoms include
cognitive function and brain MRI will be repeated.
Study burden and risks
All research data are collected through standard medical procedures and no
experimental intervention is performed. The additional risk of this study is
considered negligible. The burden of participation consists of time investment
at both baseline and follow up (120 minutes for clinical assessment and
neuropsychological testing, a maximum of 30 minutes for MRI scanning). However,
this study will contribute to knowledge of hemodynamic factors associated with
cognitive decline which form possible targets for future therapy.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Age 60-80 years (stratified in 60-65, 66-70, 71-75, 76-80 years, minimal 20
patients per group)
Knowledge of Dutch language
Permanent AF
Able to undergo MRI
Able to undergo cognitive testing
Mandatory use of coagulation
Gender stratification 50/50 (bandwidth 40%-60%)
Exclusion criteria
A clinical diagnosis of dementia is a contra-indication for participation in
this study
Other neurological or psychiatric diagnosis that affects cognitive performance
or testing, such as severe traumatic brain injury or substance abuse
A history of stroke
A pacemaker/ICD in situ >5% ventricular pacing
Severly impaired LVEF
PVI or CABG in the past three months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76057.029.21 |