Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of Blood Brain Barrier Permeability in Chronic Stroke

8. februar 2016 oppdatert av: Mordechai Lorberboym Prof, Wolfson Medical Center
In this study the investigators intend to explore the long term significance of BBB disruption on the clinical course and the rate of significant recurrent ischemic events in patients with a chronic stroke.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Evaluation of Blood Brain Barrier Permeability in Chronic Stroke

Mordechai Lorberboym, M.D.1, Yair Lampl, M.D.2, Ronit Gilad, M.D.2.

From the Department of Nuclear Medicine1 and the department of Neurology2 of the Edith Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Introduction

The blood brain barrier (BBB) is a highly selective barrier of brain microvascular endothelial cells that shields the brain from toxic substances in the blood, supplies brain tissues with nutrients, and filters harmful compounds from the brain back to the bloodstream (1). Transport across the BBB is strictly limited through both physical (tight junctions) and metabolic barriers (enzymes, diverse transport systems). BBB breakdown or alterations in transport systems play an important role in the pathogenesis of many CNS diseases (HIV-1 encephalitis, Alzheimer's disease, ischemia, tumors, multiple sclerosis, and Parkinson's disease).

Cerebral ischemia leads to disruption of blood flow, increased BBB permeability, and is associated with rapid depletion of essential nutrients and oxygen (2-3). Only a few studies were designed in humans in order to compare the degree of BBB changes and the neurological outcome after a stroke. The most significant stage of BBB breakdown occurs in humans within 48-72 hours post infarction and is accompanied by increased brain edema volume.

The investigators performed a study on thirty patients with acute stroke of the middle cerebral artery using technetium-99m-DTPA brain SPECT (4). Tc-99m-DTPA (Diethylenetriamine- pentacetic acid) brain scintigraphy is a useful technique for the assessment of BBB disruption. Is has been used in the past to localize areas within the cranium which had been disrupted by infection, neoplasms, trauma or stroke. The study showed that the magnitude of disruption of the BBB was negatively correlated with the change in neurological status with a sensitivity of 95% and a specificity of 89%. Interestingly, a significant proportion of patients with stroke (23%) had no gross evidence of BBB disruption, all of them with very good prognosis.

It is unclear for how long the BBB remains disrupted after a stroke, and whether there is any correlation between the BBB permeability and recurrent ischemic events or delayed functional and neurological outcome after a stroke.

Aim of the study

In this study the investigators intend to explore the long term significance of BBB disruption on the clinical course and the rate of significant recurrent ischemic events in patients with a chronic stroke.

Patients and methods Inclusion criteria

Male and female patients at any age with a history of a large stroke in the territory of the middle cerebral artery, occurring 1-2 years ago or between 2-5 years ago.

Exlusion criteria

Methods:

40 patients will be recruited from the Neurological Outpatient Clinic of the Edith Wolfson Medical Center and from the Neurological Department.

For the SPECT study each patient will receive 740 MBq Tc-99m-DTPA and a SPECT study will be performed 60-90- minutes later. A dual head or a triple head gamma camera is usually used, equipped with high resolution collimators.

References

  1. Persidsky Y, Ramirez SH, Haorah J, Kanmogne GD. Blood-brain barrier: structural components and function under physiologic and pathologic conditions. J Neuroimmune Pharmacol 2006;1:223-236.
  2. del Zoppo GJ, Hallenbeck JM (2000) Advances in the vascular pathophysiology of ischemic stroke. Thromb Res 98:73-81
  3. Petty MA, Wettstein JG (2001) Elements of cerebral microvascular ischaemia. Brain Res Rev 36:23-34
  4. Lorberboym M, Lampl Y, Sadeh M. Correlation of 99mTc-DTPA SPECT of the blood-brain barrier with neurologic outcome after acute stroke. J Nucl Med 2003;44:1898-1904.

Studietype

Observasjonsmessig

Registrering (Faktiske)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Holon, Israel, 58100
        • Wolfson medical center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Male and female patients at any age with a history of a large stroke in the territory of the middle cerebral artery, occurring 1-2 years ago or between 2-5 years ago.

Beskrivelse

Inclusion Criteria:

  • Male and female patients at any age with a history of a large stroke in the territory of the middle cerebral artery, occurring 1-2 years ago or between 2-5 years ago.

Exclusion Criteria:

  • Lacunar strokes,
  • CNS lesions other than a stroke,
  • unable to perform the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Blood Brain Barrier permeability
Tidsramme: 2 years
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. november 2011

Datoer for studieregistrering

Først innsendt

15. september 2010

Først innsendt som oppfylte QC-kriteriene

15. september 2010

Først lagt ut (Anslag)

16. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 0056-09-WOMC

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på A Positive or a Negative Brain SPECT

3
Abonnere