- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04668261
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Jorn Fierstra, MD, PhD
- Telefonnummer: 0041 442553169
- E-post: jorn.fierstra@usz.ch
Studera Kontakt Backup
- Namn: Luca Regli, Professor
- Telefonnummer: 0041442552992
- E-post: Luca.regli@usz.ch
Studieorter
-
-
-
Zurich, Schweiz, 8032
- Rekrytering
- University Hospital Zurich
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria
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
- 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
Exclusion criteria:
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
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Neurosurgical patients
• Neurosurgical diseases with the potential to alter blood flow to the brain:
|
MRI imaging
|
Healthy subjects
|
MRI imaging
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Tidsram: 5 years
|
blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements
|
5 years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2020-02314
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