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Vascular Risk Factors in INPH-patients

Vascular Risk Factors, Subclinical and Manifest Vascular Disease in Patients With Idiopathic Normal Pressure Hydrocephalus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01850914
Enrollment
860
Registered
2013-05-10
Start date
2010-01-31
Completion date
2012-07-31
Last updated
2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases, Central Nervous System Diseases, Hydrocephalus, Normal Pressure, Nervous System Diseases, Vascular Diseases

Keywords

Normal pressure hydrocephalus, Vascular risk factors

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.

Interventions

None listed

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in bloodpressure between INPH-patients and a sex- and agematched community based populationMore than two weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.

Secondary

MeasureTime frameDescription
Quality of Life in INPH-patients compared to a sex- and age-matched population.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.

Other

MeasureTime frameDescription
Differences between INPH-patients and community based controls regarding dietary risk score.More than 2 weeks, not more than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding physical activity.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding diabetes mellitus.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding alcohol intake.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding psychosocial factors.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding cardiac causes.More than two weeks, not longer than 6 weeks.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding smoking.More than two weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding activities of daily life (ADL).More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding frequency, severity and fear of falling.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding headache.More than2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding epilepsy.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding kidney function.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding ratio of apolipoprotein B to A1.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.
Differences between INPH-patients and community based controls regarding waist-to-hip ratio.More than 2 weeks, not longer than 6 months.Enrollment of participants 2010-2012. First, all participants complete a questionnaire, second they go to their local health care center or nearby hospital for measurements and blood samples. The visit at the health care center/hospital is within a couple of months. Participants are not followed further (cross-sectional study). Analyses performed 2013-2014. First results approximately reported in the end of 2013.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026