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Completed

NCT Number: NCT01850914

Vascular Risk Factors in INPH-patients

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.

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Key information

Conditions

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

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience

Umeå, Västerbotten County, 901 87, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 10, 2013
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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