Clinical trial NCT01850914: Vascular Risk Factors in INPH-patients
Official title: Vascular Risk Factors, Subclinical and Manifest Vascular Disease in Patients With Idiopathic Normal Pressure Hydrocephalus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus, Normal Pressure
Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Keywords: Normal pressure hydrocephalus
Vascular risk factors
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 860
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cases are all INPH-patients who underwent surgery 2008-2010 and are registered in the Swedish National Register of Hydrocephalus. Controls were found in the Swedish population indox of Umeå, and were indivdually matched to cases according to age and sex.

Brief summary: Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk factors and vascular disease in shunted INPH-patients compared to an age- and sex matched elderly population, as well as the impact of vascular risk factors and vascular co-morbidity on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that INPH-patients have a higher level of vascular risk factors and subclinical organ damage than a normal elderly population, and that the higher the level of existing vascular risk factors, the more severe the symptoms of the hydrocephalic disease.


Eligibility criteria: Inclusion Criteria:

* INPH-patients who underwent surgery 2008-2010 and registered in the Swedish National Register of Hydrocephalus
* age \<60 and \>85
* (only for controls) living in Umeå

Exclusion Criteria:

* death
* a known mini mental state estimation \<23
* inability to communicate (because of severe stroke, aphasia, dementia)
* (only for controls) individuals with INPH who has not yet underwent surgery, or has not been chosen to undergo surgery.

Primary outcomes:
measure: Differences in bloodpressure between INPH-patients and a sex- and agematched community based population
timeFrame: More than two weeks, not longer than 6 months.
Secondary outcomes:
measure: Quality of Life in INPH-patients compared to a sex- and age-matched population.
timeFrame: More than 2 weeks, not longer than 6 months.
Other outcomes:
measure: Differences between INPH-patients and community based controls regarding smoking.
timeFrame: More than two weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding waist-to-hip ratio.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding dietary risk score.
timeFrame: More than 2 weeks, not more than 6 months.
measure: Differences between INPH-patients and community based controls regarding physical activity.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding diabetes mellitus.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding alcohol intake.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding psychosocial factors.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding cardiac causes.
timeFrame: More than two weeks, not longer than 6 weeks.
measure: Differences between INPH-patients and community based controls regarding ratio of apolipoprotein B to A1.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding activities of daily life (ADL).
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding frequency, severity and fear of falling.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding headache.
timeFrame: More than2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding epilepsy.
timeFrame: More than 2 weeks, not longer than 6 months.
measure: Differences between INPH-patients and community based controls regarding kidney function.
timeFrame: More than 2 weeks, not longer than 6 months.
Locations:
city: Umeå
country: Sweden
facility: Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience
state: Västerbotten
Study officials:
affiliation: Umeå University, Departement of Pharmacology and Clinical Neuroscience
name: Jan Malm, MD, PhD
role: STUDY_DIRECTOR
affiliation: Umeå University, Departement of Pharmacology and Clinical Neuroscience
name: Hanna Israelsson, MD, PhD-stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eklund SA, Israelsson H, Carlberg B, Malm J. Vascular risk profiles for predicting outcome and long-term mortality in patients with idiopathic normal pressure hydrocephalus: comparison of clinical decision support tools. J Neurosurg. 2022 Jun 10;138(2):476-482. doi: 10.3171/2022.4.JNS22125. Print 2023 Feb 1.