Vascular Risk Factors in INPH-patients

NCT01850914 | Completed

• 2 other identifiers: 2011-52-31MDnr 2011-52-31M
• Study Type: observational
• Target: 860
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Normal pressure hydrocephalus; Vascular risk factors

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Quality of Life in INPH-patients compared to a sex- and age-matched population.

  More than 2 weeks, not longer than 6 months.

Other Outcomes (14)

• Differences between INPH-patients and community based controls regarding smoking.

  More than two weeks, not longer than 6 months.

• Differences between INPH-patients and community based controls regarding waist-to-hip ratio.

  More than 2 weeks, not longer than 6 months.

• Differences between INPH-patients and community based controls regarding dietary risk score.

  More than 2 weeks, not more than 6 months.

Study Arms (2)

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 Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

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

Umeå, Västerbotten County, 901 87, Sweden

Location

Related Publications (1)

• Eklund SA, Israelsson H, Carlberg B, Malm J. Vascular risk profiles for predicting outcome and long-term mortality in patients with idiopathic normal pressure hydrocephalus: comparison of clinical decision support tools. J Neurosurg. 2022 Jun 10;138(2):476-482. doi: 10.3171/2022.4.JNS22125. Print 2023 Feb 1.

  PMID: 35901765 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hydrocephalus; Cardiovascular Diseases

Study Officials

• Jan Malm, MD, PhD

  Umeå University, Departement of Pharmacology and Clinical Neuroscience

  STUDY DIRECTOR

• Hanna Israelsson, MD, PhD-stud

  Umeå University, Departement of Pharmacology and Clinical Neuroscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: May 10, 2013
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

SE (1)