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Assessment and Quantification of Collateral by ASL MRI

1. februar 2017 oppdatert av: Xin Lou, Chinese PLA General Hospital

Arterial Spin Labeling MRI Assessment and Quantification of Collateral Circulation in Unilateral Middle Cerebral Artery Atherosclerotic Stenosis

Collateral circulation supports brain tissues to maintain blood perfusion in cerebral ischemic stroke and are of great benefit for a better outcome. A non-invasive approach relative to currently widely used digital subtraction angiography (DSA) is needed. ASL (arterial spin labeling) is a novel perfusion method without contrast agent injection and features both temporal and cerebral blood flow(CBF) information. The investigators applied multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL) MRI and subtraction images were obtained to evaluate the collateral robustness and quantitatively assess the collateral perfusion in patients with unilateral middle cerebral artery atherosclerotic stenosis and the ability to predict future stroke recurrence.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

Patients with unilateral middle cerebral artery (MCA) moderate to severe stenosis were consecutively enrolled. MRI protocols including diffusion weighted image, magnetic resonance angiography , 3D pCASL with two PLD of 1.5s and 2.5s were performed.

Cerebral blood flow(CBF) map of 3D pCASL with PLD 1.5s and 2.5s were postprocessed on workstation. Subtraction images were obtained by CBF 2.5s subtracted CBF 1.5s. Slices involving MCA downstream territory were equally separated as upper slices,middle slices and inferior slices corresponding to CIS system referring to previous study of Al-Ali F. Slices with residual signal areas more than 1/3 MCA territory involved would count 1, or would be 0. Total ASL collateral score(ASLCS) was calculated from 0-3. Then ,favorable collaterals were graded as total ASLCS 2-3 and poor collaterals were graded as total ASLCS 0-1.

Early-arriving flow perfusion proportion was defined as [CBF 1.5s at lesion side/CBF 2.5s of the contralateral side]×100%. Late-arriving perfusion proportion was defined as [(CBF 2.5s minus CBF 1.5s) at lesion side minus (CBF 2.5s minus CBF 1.5s) at normal side]/CBF 2.5s at the contralateral side ×100%. Antegrade scales and collateral grades were evaluated in patients with conventional angiography. Spearman correlation was analyzed between early-arriving and late-arriving flow and angiographic antegrade and collateral scales.

Baseline characteristics of patients were recorded including age, gender, hypertension,hypercholesterolemia,diabetes mellitus,smoking,obesity,qualifying stroke event, admission National Institute of Health stroke scale (NIHSS), diffusion-weighted image-ASPECTS.

One year stroke event recurrence and three months modified Rankin Scale (mRS) were followed up by neurologist by phone call or face to face.

Multi-variants Logistic Regression is performed to exam whether ASL collateral score and collateral perfusion quantification is significantly correlated with future ischemic event and functional outcome.

Studietype

Observasjonsmessig

Registrering (Forventet)

60

Kontakter og plasseringer

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Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Rekruttering
        • Chinese PLA General Hospital

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 til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Symptomatic and asymptomatic patients with MCA atherosclerotic moderate to severe stenosis(500%-99%) confirmed by conventional angiography or magnetic resonance angiography.

Beskrivelse

Inclusion Criteria:

  • Ischemic stroke or TIA in anterior circulation within 90 days
  • MCA atherosclerotic moderate to severe stenosis(50%-99%) confirmed by conventional angiography or magnetic resonance angiography
  • Age >18
  • 2 or more atherosclerotic risk factors including hypertension, hypercholesterolemia, diabetes mellitus, cigarette smoking, and obesity
  • Medical treatment
  • Not receiving stent therapy
  • Ability to comply with all studies

Exclusion Criteria:

  • Multiple intracranial arteries stenosis (> 50%) or occlusion
  • Less than 2 atherosclerotic risk factors
  • Pregnancy and other contraindication to MRI scan
  • Informed consent not obtained

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Collateral Circulation
Symptomatic patients with unilateral MCA severe stenosis confirmed ≥ 90% by magnetic resonance angiography or 70-99% by conventional angiography were performed 3D pseudo-Continuous Arterial Spin Labeling MRI.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stroke Event
Tidsramme: Up to 1 year
The patients were monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
Up to 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
modified Rankin Score
Tidsramme: 3 months
mRS of patients with acute or subacute stroke after 3 months were followed up for neurological outcome assessment. mRS < 2 was defined as favorable neurological outcome and mRS ≥ 2 was defined as poor neurological outcome.
3 months

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Studiestol: Xin Lou, MD, PHD., Chinese PLA General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. januar 2014

Primær fullføring (Forventet)

1. desember 2017

Studiet fullført (Forventet)

1. desember 2017

Datoer for studieregistrering

Først innsendt

19. juni 2015

Først innsendt som oppfylte QC-kriteriene

23. juni 2015

Først lagt ut (Anslag)

24. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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