Brain Blood Flow ImpairmentNCT04668261
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
An observational study of Brain Blood Flow Impairment, run by University of Zurich at 1 site in Switzerland.
Trial summary
Primary study objective: Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Blood Flow Impairment
- What is being tested?
- Advanced imaging investigation
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurosurgical patients with the potential to have altered blood flow to the brain
Who may be able to join
- Patients:
- Male and Female subjects >18 years of age
- Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator
- Neurosurgical diseases with the potential to alter blood flow to the brain:
- Cerebrovascular disease
- Brain tumors
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- Normal Pressure Hydrocephalus
- Healthy subjects:
- Male and Female subjects >18 years of age
- Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator
Who cannot join
- Patients:
- Unwilling or unable to co-operate with breathing maneuvers
- Respiratory or cardiac limitations to breathing through a mask
- Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Standard contraindications for MRI scanning
- Verbal confirmed pregnancy
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- Known multiple intracranial diseases
- Presence of intracranial hemorrhage within the last 3 months
- Symptomatic increased intracranial pressure
- Healthy subjects:
- Unwilling or unable to co-operate with breathing maneuvers
- Respiratory or cardiac limitations to breathing through a mask
- Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Standard contraindications for MRI scanning
- Verbal confirmed pregnancy
- Anamnesticly a history of neurological disease or current neurological deficits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8032
About this study
Primary study objective:
- Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Secondary study objectives:
- Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
- Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
- Determining hemodynamic imaging patterns that can be tested as novel imaging markers.
Read the detailed description
Primary study objective:
- to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.
Secondary study objectives:
- To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
- To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.
4.2 Outcomes
Outcomes of the project:
Primary endpoint:
To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.
Secondary endpoints:
- Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
- Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.
- Conditions
- Brain Blood Flow Impairment
- Being tested
- Advanced imaging investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced imaging investigationOther
MRI imaging
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgical patients | • Neurosurgical diseases with the potential to alter blood flow to the brain:
* Cerebrovascular disease
* Brain tumors
* Normal Pressure Hydrocephalus Receives: Other: Advanced imaging investigation | |
| Healthy subjects | * Male and Female subjects >18 years of age
* Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator Receives: Other: Advanced imaging investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Blood Flow ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668261
- Sponsor's protocol ID
- 2020-02314
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT04668261
- Acronym / sponsor ID
- 2020-02314
- Conditions
- Brain Blood Flow Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 16 Dec 2020 (actual)
- 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.
Primary study objective:
- Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Secondary study objectives:
- Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
- Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
- Determining hemodynamic imaging patterns that can be tested as novel imaging markers.
Detailed description
Primary study objective:
- to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.
Secondary study objectives:
- To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
- To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.
4.2 Outcomes
Outcomes of the project:
Primary endpoint:
To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.
Secondary endpoints:
- Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
- Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurosurgical patients | – | Other: Advanced imaging investigation• Neurosurgical diseases with the potential to alter blood flow to the brain: * Cerebrovascular disease * Brain tumors * Normal Pressure Hydrocephalus |
| Healthy subjects | – | Other: Advanced imaging investigation* Male and Female subjects >18 years of age * Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgical patients with the potential to have altered blood flow to the brain
Key inclusion criteria (10 listed)
- Male and Female subjects >18 years of age
- Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator
- Neurosurgical diseases with the potential to alter blood flow to the brain:
- Male and Female subjects >18 years of age
- Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator
Key exclusion criteria (16 listed)
- Unwilling or unable to co-operate with breathing maneuvers
- Respiratory or cardiac limitations to breathing through a mask
- Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Standard contraindications for MRI scanning
- Verbal confirmed pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced imaging investigationMRI imaging | Other | Healthy subjects, Neurosurgical patients |
Primary outcome
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Time frame: 5 years
blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Brain Blood Flow Impairment, run by University of Zurich at 1 site in Switzerland.
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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Dec 2020. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorn Fierstra, MD, PhD (0041 442553169, jorn.fierstra@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2020.