Vascular Risk Factors in INPH-patients

NCT ID: NCT01850914

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 860 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Shunted patients with INPH

Cases: Patients with normal pressure hydrocephalus who have underwent surgery. Controls: Sex- and age-matched community based controls.

No interventions assigned to this group

Populationbased elderly.

A group of populationbased elderly, matched according to age and sex to the patients with INPH. Vascular risk factors studied.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Hanna Israelsson

MD, PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Malm, MD, PhD

Role: STUDY_DIRECTOR

Umeå University, Departement of Pharmacology and Clinical Neuroscience

Hanna Israelsson, MD, PhD-stud

Role: PRINCIPAL_INVESTIGATOR

Umeå University, Departement of Pharmacology and Clinical Neuroscience

Locations

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

Umeå, Västerbotten County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35901765 (View on PubMed)

Other Identifiers

Dnr 2011-52-31M

Identifier Type: OTHER

Identifier Source: secondary_id

2011-52-31M

Identifier Type: -

Identifier Source: org_study_id