1) to investigate whether hypertensive patients with WMLs decline more strongly in cognitive function than hypertensive patients without WMLs in a 4-year time period. 2) to identify predictors for cognitive dysfunction in hypertension/SVD patients…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Cognitive and attention disorders and disturbances
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The degree of SVD (WMLs, LACIs, and BMBs) and cognitive functioning.
Secondary outcome
Haptoglobin polymorphism and EPC-activity.
Other cerebral abnormalities observed by MRI: atrophy and other cerebral
abnormalities.
Background summary
Hypertension is a major risk factor for cerebral small vessel disease (SVD)
(Spence, 1996), which causes white matter lesions (WML), small deep subcortical
ischemic lesions (lacunar infarcts, LACI) (Pantoni, Poggesi, & Inzitari, 2007)
and brain microbleeds (BMBs) (Henskens, van Oostenbrugge, Kroon, de Leeuw, &
Lodder, 2008). WMLs, in particular located periventricularly, predict cognitive
decline and conversion to dementia (Debette et al., 2007). Although
hypertension constitutes a major risk factor in SVD and the related cognitive
decline, it cannot account for all the risk (Vermeer, Longstreth, & Koudstaal,
2007). Therefore, other risk factors need to be investigated in order to
disentangle the complex model of the pathogenesis of SVD-mediated cognitive
decline. Effects of the haptoglobin polymorphism (Staals et al., 2008) and
EPC-activity (Rouhl) on WMLs have been found recently. In this study, we would
like to explore the associations of these variables with cognition.
It is expected that hypertension indirectly influences the degree of cognitive
dysfunction, and is mediated by the extent of SVD. It is expected that more
severe hypertension is associated with more severe SVD, which in turn is
negatively related to cognitive functioning. The relation of the haptoglobin
polymorphism and EPC-activity with cognition will be explored.
Study objective
1) to investigate whether hypertensive patients with WMLs decline more strongly
in cognitive function than hypertensive patients without WMLs in a 4-year time
period.
2) to identify predictors for cognitive dysfunction in hypertension/SVD
patients.
Study design
Prospective, observational, follow-up cohort study
Study burden and risks
Patients undergo non-invasive magnetic resonance imaging (MRI) of the brain and
a neuropsychological assessment. The choice of the study group is essential
since these patients may have a wide range of SVD-related brain damage (from
none to extensive WMLs, LACIs and BMBs), but still are a-symptomatic. Since
WMLs, LACIs and BMBs cannot be undone, but the possible risk factors of this
SVD (a.o. hypertension) can be treated, it is of clinical relevance to study
the role of these risk factors.
P.Debyelaan 25
Maastricht 6229 HX
NL
P.Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria
- Patients who participated in the HYBRiD- study
- Consent for being contacted for follow-up studies
- Essential hypertension:
o Use of antihypertensive medication at first visit of the hypertension clinic, or
o Office blood pressure: *140 and/ or *90 mmHg (average of 3 measurements with intervals of 2 minutes minimum, or
o ABPM blood pressure: *125 and/ or *80 mmHg (average of 24 hours).
- Caucasian
- Age between 18 and 90 years
- Ambulant
Exclusion criteria
- - Cerebrovascular abnormalities in anamnesis
o TIA in 6 months before anamnesis
o Brain infarction
o Haemorrhage (subarachnoid or intracerebral)
- Contra indications for MRI
o Heart valve prosthesis
o Pacemaker
o Intracerebral clips (aneurysm)
o Intra-ocular metal pieces
o Cochlear implant
o Claustrophobia
- When the patient does not appreciate to receive the results of the study, in particular if abnormalities are found during MRI or neuropsychological assessment, which are of great importance for the patients health.
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 | NL24559.068.09 |