Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages
18. oktober 2017 opdateret af: Rajeev K Garg, Rush University Medical Center
The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to weakening by age, high blood pressure, and/or elevated cholesterol.
In addition to artery rupture, recent data suggests that patients with ICH are also at risk for developing occlusion of arteries during the acute phase, called ischemic strokes.
Data suggests these ischemic strokes can negatively impact patient outcomes.
Diffusion weighted imaging (DWI) is a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic strokes in the brain.
In this proposal, our primary aim is examine prospectively the effect DWI abnormalities have on functional outcomes in patients with ICH.
Our hypothesis is that the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in patients with ICH
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
Diffusion weighted imaging (DWI) is a sensitive method to assess for secondary ischemia in patients with acute brain injury.
By comparing the outcomes of patients with and without DWI abnormalities, we would able to assess the impact these lesions have on functional recovery in patients with ICH.
Since no direct therapies exist for this disease, DWI abnormalities may be a novel target for intervention to improve outcomes.
If traditionally assessed functional outcomes are not affected by DWI, the mechanism behind these lesions would still warrant further evaluation and potential treatment.
Detection of subclinical infarcts has emerged as a potential surrogate marker for subsequent risk of stroke, vascular dementia, and cognitive impairment.
Furthermore, the cause behind DWI lesions in acute ICH may lead to better understanding the pathophysiologic interplay between ischemic and hemorrhagic strokes.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
130
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 79 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects for this study will be selected from patients admitted with a primary intracerebral hemorrhage to Rush University Medical Center's Neurosciences Intensive Care Unit.
Beskrivelse
Inclusion Criteria:
- Patients > 18 years and < 80 years
- Spontaneous intracerebral hemorrhage documented by CT scan
- Less than 24 hours from time last seen normal to first medical evaluation
- No prior clinical history of stroke (i.e. subarachnoid hemorrhage, ICH, or ischemic strokes)
Exclusion Criteria:
- Pregnancy
- History of cancer
- Pre-admission mRS > 2
- Glasgow Coma Scale less than 5
- ICH secondary to aneurysm, vascular malformation, mycotic aneurysm, primary or metastatic tumor, trauma, warfarin-related ICH, acute-fibrinolytic associated ICH, or coagulopathy
- Associated epidural or subdural hematoma
- Surgical intervention < 48 hours from admission
- Hemodynamic instability (need for vasopressor therapy)
- Acute hypoxemic or hypercapnic respiratory failure
- History of deep venous thrombosis
- Contraindications to MRI based upon institutional safety checklist
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Spontaneous Intracerebral Hemorrhage
Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Rankin Scale (mRS)
Tidsramme: 3 months
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Modified Rankin Scale (mRS)
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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National Institutes of Health Stroke Scale
Tidsramme: 14 days or discharge
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National Institutes of Health Stroke Scale
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14 days or discharge
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Modified Rankin Scale (mRS)
Tidsramme: 14 days
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Modified Rankin Scale (mRS)
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14 days
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Modified Rankin Scale (mRS)
Tidsramme: 6 months
|
Modified Rankin Scale (mRS)
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rajeev K Garg, MD, Rush University Medical Center Deparment of Neurological Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2011
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først indsendt
12. august 2011
Først indsendt, der opfyldte QC-kriterier
15. august 2011
Først opslået (Skøn)
16. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11011402
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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