Vascular Risk Factors in INPH-patients

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850914
• Other study ID #: 2011-52-31M
• Secondary ID: Dnr 2011-52-31M
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: May 27, 2013
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Sweden	Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences between INPH-patients and community based controls regarding smoking.	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.	More than two weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding waist-to-hip ratio.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding dietary risk score.	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.	More than 2 weeks, not more than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding physical activity.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding diabetes mellitus.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding alcohol intake.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding psychosocial factors.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding cardiac causes.	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.	More than two weeks, not longer than 6 weeks.	No
Other	Differences between INPH-patients and community based controls regarding ratio of apolipoprotein B to A1.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding activities of daily life (ADL).	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding frequency, severity and fear of falling.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding headache.	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.	More than2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding epilepsy.	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.	More than 2 weeks, not longer than 6 months.	No
Other	Differences between INPH-patients and community based controls regarding kidney function.	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.	More than 2 weeks, not longer than 6 months.	No
Primary	Differences in bloodpressure between INPH-patients and a sex- and agematched community based population	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.	More than two weeks, not longer than 6 months.	No
Secondary	Quality of Life in INPH-patients compared to a sex- and age-matched population.	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.	More than 2 weeks, not longer than 6 months.	No