Vascular Risk Factors in INPH-patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanna Israelsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01850914
First received: April 4, 2013
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Vascular Risk Factors, Subclinical and Manifest Vascular Disease in Patients With Idiopathic Normal Pressure Hydrocephalus

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Differences between INPH-patients and community based controls regarding smoking. [ Time Frame: More than two weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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 dietary risk score. [ Time Frame: More than 2 weeks, not more than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than two weeks, not longer than 6 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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). [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: More than 2 weeks, not longer than 6 months. ] [ Designated as safety issue: No ]
    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.


Enrollment: 860
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850914

Locations
Sweden
Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience
Umeå, Västerbotten, Sweden, 901 87
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Hanna Israelsson, MD, PhD-student, Umeå University
ClinicalTrials.gov Identifier: NCT01850914     History of Changes
Other Study ID Numbers: 2011-52-31M, Dnr 2011-52-31M
Study First Received: April 4, 2013
Last Updated: May 27, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Normal pressure hydrocephalus
Vascular risk factors

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Hydrocephalus
Hydrocephalus, Normal Pressure
Nervous System Diseases
Vascular Diseases
Intracranial Hypertension
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014