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PET-MRI Imaging in Patients With Acute Neurovascular Syndrome

10. februar 2020 opdateret af: University of Edinburgh

Hybrid 18F-Fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Acute Acute Neurovascular Syndrome

Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Two cohorts of patients with evidence of an acute stroke, transient ischaemic attack or amaurosis fugax will be recruited as early as possible, but within 14 days of symptom onset. All patients will undergo careful clinical evaluation including carotid Doppler ultrasound assessment and magnetic resonance imaging of the brain.

Beskrivelse

Inclusion Criteria:

  1. Patients above 40 years of age with carotid artery stenosis that do not achieve criteria for CEA (<50% for men, <70% for women, by NASCET criteria) or the patient has declined CEA.
  2. Patients above 40 years of age with atherosclerotic disease of aortic arch and its branches.

Exclusion Criteria:

  1. Patients with new stroke and a modified Rankin score >3
  2. Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of <30 ml/min/1.73 m2
  3. Atrial fibrillation
  4. Pregnant women
  5. Prior ipsilateral carotid intervention
  6. Prior neck radiotherapy
  7. Inability to tolerate the supine position
  8. Participation in the study would result in delay to surgery
  9. Psychiatric illness/social situations that would limit compliance with study requirements
  10. History of allergic reaction attributed to 18F-Fluoride
  11. History of allergic reaction to gadolinium contrast media
  12. Metal implants or devices including pacemakers and defibrillators

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
Intervention / Behandling
Carotid
Patients with carotid artery stenosis who either do not meet surgical criteria (< 50% by NASCET criteria for men, <70% for women), or meet criteria but do not undergo surgery (surgery declined or not offered) and are currently treated with OMT. This cohort will be recruited from the acute TIA clinics and Vascular Laboratory logbooks at Edinburgh Royal Infirmary and Western General Hospital.
Stråling: 18F PET-MRI
18F-fluoride Hybrid PET-MRI
Diagnostisk test: Transcranial Doppler
Microembolic Signals detection
Non Carotid
Patients with an atherosclerotic disease in the aortic arch including origins of its major branches other than the internal carotid artery treated with OMT. Patients with a cardiac source of embolism will be excluded from the study. This group will be recruited from the acute TIA clinics and inpatients at Edinburgh Royal Infirmary and Western General Hospital.
Stråling: 18F PET-MRI
18F-fluoride Hybrid PET-MRI
Diagnostisk test: Transcranial Doppler
Microembolic Signals detection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels.
Tidsramme: 2 weeks
18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques.
2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Edinburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

12. oktober 2017

Primær færdiggørelse (Faktiske)

10. januar 2020

Studieafslutning (Faktiske)

10. januar 2020

Datoer for studieregistrering

Først indsendt

14. juni 2017

Først indsendt, der opfyldte QC-kriterier

10. juli 2017

Først opslået (Faktiske)

12. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AC17058

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med 18F PET-MRI

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Betingelser

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Kosttilskud

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Placeringer

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