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

April 4, 2013
May 27, 2013
January 2010
July 2012   (final data collection date for primary outcome measure)
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.
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 bloodsamples. 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.
Complete list of historical versions of study NCT01850914 on ClinicalTrials.gov Archive Site
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.
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 bloodsamples. 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. [ 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.
  • 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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 bloodsamples. 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.
 
Vascular Risk Factors in INPH-patients
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

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.

  • Hydrocephalus, Normal Pressure
  • Vascular Diseases
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
860
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
60 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01850914
2011-52-31M, Dnr 2011-52-31M
No
Hanna Israelsson, Umeå University
Umeå University
Not Provided
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
Umeå University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP