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MicroRNA Diagnostics in Subarachnoid Hemorrhage

7 april 2014 bijgewerkt door: Søren Bache Larsen, MD, Rigshospitalet, Denmark

MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia

The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).

We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.

At first we wish to compare the expression of 376 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus.

Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.

Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.

In addition, some of the patients as part of another clinical trial (NCT01447095

) will have established invasive neuromonitoring including microdialysis. It is our intention to develop a method for analyzing microRNA in this microdialysate.

DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:

"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."

Studietype

Observationeel

Inschrijving (Werkelijk)

50

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Copenhagen, Denemarken, 2400
        • Bispebjerg Hospital
      • Copenhagen, Denemarken, 1302
        • Rigshospitalet

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Group 1+2: Patients admitted to Neurointensive Department in Rigshospitalet. Group 3: Patients undergoing spinal anesthesia for orthopedic surgery in Bispebjerg Hospital.

Beschrijving

Inclusion Criteria:

  • Patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage
  • External ventricular drainage with 5 days of ictus
  • Age > 18 years

Exclusion Criteria:

  • Glasgow Coma Score (GCS) continuously < 7 during the first 5 days following ictus
  • A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a GCS < 7 thereby preventing the detection of DCI.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
SAH with DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
SAH without DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
Neurological healthy controls
12 patients (ASA 1) undergoing spinal anesthesia for orthopedic surgery have 2 ml of cerebrospinal fluid drawn preceding injection of local analgetic.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Delayed Cerebral Ischemia - Clean groups
Tijdsspanne: 21 days

Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

We found confirmation/exclusion of DCI difficult in a few patients. To minimize error, two clinicians reviewed all clinical, biochemical and radiological data, obtained 3 weeks from ictus, and independently assessed if any clinical deterioration fulfilled the criteria of delayed cerebral ischemia. Furthermore, included patients were categorized as "definitely DCI", "probably DCI", "probably not DCI" or "definitely not DCI".

Therefore we decided to modify our primary outcome measure in this case-control study to compare "definitely DCI" vs. "definitely not DCI".
21 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm
Tijdsspanne: Assessed at the first wake-up call following clip or coil

Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their clinical neurology at the first wake-up call following occlusion of the aneurysm:

  1. GCS 3-12 and/or (paresis (degree 4) of at least one extremity or aphasia)
  2. GCS 13-15 and no or only small and mild focal deficit
Assessed at the first wake-up call following clip or coil
Association of microRNA-profile with 3 month outcome
Tijdsspanne: Follow up examination at 3 month or as close to this

Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their mRS at 3 month follow-up in groups:

  1. mRS = 3-6
  2. mRS = 0-2
Follow up examination at 3 month or as close to this
Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups.
Tijdsspanne: 21 days following ictus

Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

In contrast to our primary outcome measure, these groups will include patients where DCI was difficult to exclude or confirm.

Thereby we wish to compare "definitely DCI" and "probably DCI" vs. "probably not DCI" and "definetly not DCI". This would enable comparison between larger groups though less clean.
21 days following ictus
Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.
Tijdsspanne: Following a blinded description of CT-scans
The presence of cerebral infarction on CT or MR scan of the brain within 6 weeks after SAH, or on the latest CT or MR scan made before death within 6 weeks, or proven at autopsy, not present on the CT or MR scan between 24 and 48 hours after early aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities on CT imaging resulting from ventricular catheter or intraparenchymal hematoma should not be regarded as cerebral infarctions from DCI.
Following a blinded description of CT-scans
Relation of microRNA profile to the regional area of cerebral injury
Tijdsspanne: Following a blinded description of CT-scans
As microRNAs seem to be specific for different areas of the brain our screening might tell us which area has sustained injury and which has not. This study will not include two groups as the secondary outcome measures above.
Following a blinded description of CT-scans

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rigshospitalet, Denmark

Medewerkers

Bispebjerg Hospital

Onderzoekers

  • Hoofdonderzoeker: Søren B Larsen, MD, Rigshopsitalet, Denmark
  • Studie stoel: Kirsten Møller, DMSci, Rigshospitalet, Denmark

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2013

Primaire voltooiing (Werkelijk)

1 januari 2014

Studie voltooiing (Werkelijk)

1 januari 2014

Studieregistratiedata

Eerst ingediend

12 februari 2013

Eerst ingediend dat voldeed aan de QC-criteria

12 februari 2013

Eerst geplaatst (Schatting)

13 februari 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

8 april 2014

Laatste update ingediend die voldeed aan QC-criteria

7 april 2014

Laatst geverifieerd

1 april 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MicroRNA in SAH

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