Vascular Risk Factors in INPH-patients

May 27, 2013 updated by: Hanna Israelsson, Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

860

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 901 87
        • Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Shunted patients with INPH
Cases: Patients with normal pressure hydrocephalus who have underwent surgery. Controls: Sex- and age-matched community based controls.
Populationbased elderly.
A group of populationbased elderly, matched according to age and sex to the patients with INPH. Vascular risk factors studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in bloodpressure between INPH-patients and a sex- and agematched community based population
Time Frame: 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.
More than two weeks, not longer than 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in INPH-patients compared to a sex- and age-matched population.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between INPH-patients and community based controls regarding smoking.
Time Frame: 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.
More than two weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding waist-to-hip ratio.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding dietary risk score.
Time Frame: 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.
More than 2 weeks, not more than 6 months.
Differences between INPH-patients and community based controls regarding physical activity.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding diabetes mellitus.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding alcohol intake.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding psychosocial factors.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding cardiac causes.
Time Frame: 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.
More than two weeks, not longer than 6 weeks.
Differences between INPH-patients and community based controls regarding ratio of apolipoprotein B to A1.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding activities of daily life (ADL).
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding frequency, severity and fear of falling.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding headache.
Time Frame: 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.
More than2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding epilepsy.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.
Differences between INPH-patients and community based controls regarding kidney function.
Time Frame: 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.
More than 2 weeks, not longer than 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Study Director: Jan Malm, MD, PhD, Umeå University, Departement of Pharmacology and Clinical Neuroscience
  • Principal Investigator: Hanna Israelsson, MD, PhD-stud, Umeå University, Departement of Pharmacology and Clinical Neuroscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-52-31M
  • Dnr 2011-52-31M (OTHER: Regional Ethics Board in Umeå)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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