Hydrocephalus, Normal PressureNCT01850914
Vascular Risk Factors in INPH-patients
An observational study of Hydrocephalus, Normal Pressure and Vascular Diseases, run by Umeå University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Hydrocephalus, Normal Pressure, Vascular Diseases, Brain Diseases
- How many people
- 860 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå University, Umeå University Hospital, Departement of Pharmacology and Clinical Neuroscience
Umeå, Västerbotten County, 901 87
About this study
Official title: 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.
- Conditions
- Hydrocephalus, Normal Pressure, Vascular Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Normal pressure hydrocephalus, Vascular risk factors
- Medical subject headings
- Hydrocephalus, Normal Pressure, Vascular Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: More than 2 weeks, not longer than 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Israelsson, Umeå University
- Investigators
- Jan Malm, MD, PhD, Study director, Umeå University, Departement of Pharmacology and Clinical NeuroscienceHanna Israelsson, MD, PhD-stud, Principal investigator, Umeå University, Departement of Pharmacology and Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850914
- Sponsor's protocol ID
- 2011-52-31M
- Other IDs
- Dnr 2011-52-31M
- Status last verified
- May 2013
- First submitted
- 4 Apr 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35901765
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Risk Factors, Subclinical and Manifest Vascular Disease in Patients With Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT01850914
- Acronym / sponsor ID
- 2011-52-31M
- Conditions
- Hydrocephalus, Normal Pressure, Vascular Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Keywords
- Normal pressure hydrocephalus, Vascular risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Derived from this study: PubMed 35901765Eklund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Malm, MD, PhD study director
Umeå University, Departement of Pharmacology and Clinical Neuroscience
Hanna Israelsson, MD, PhD-stud principal investigator
Umeå University, Departement of Pharmacology and Clinical Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, Normal Pressure and Vascular Diseases, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.