Vascular Risk Factors in INPH-patients

Completed

• Conditions: Hydrocephalus, Normal Pressure; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

• Registration Number: NCT01850914
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2013-04-04
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-10
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in bloodpressure between INPH-patients and a sex- and agematched community based population	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience; 🇸🇪 Umeå, Västerbotten, Sweden