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Cognitive Outcome After Carotid Surgery

22. november 2019 oppdatert av: Lahey Clinic

The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or worsening of thinking or memory. There have been many studies on this subject, some finding that certain patients gain improvement in their brain function and others might get worse. The goal of this study is to discover which patients are more likely to have improved cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and stenting (CAS) are not investigational and are an accepted treatment for your condition. In addition, subjects that choose not to undergo surgery will also be included in this study.

Studieoversikt

Status

Fullført

Forhold

Carotis stenose

Detaljert beskrivelse

At the present time, large multi-center clinical trials support the use of carotid revascularization for symptomatic carotid stenosis and for asymptomatic carotid stenosis (greater than 60%) to prevent stroke. Guidelines supporting the use of carotid endarterectomy for asymptomatic stenosis are based largely on the Asymptomatic Carotid Atherosclerosis Study (ACAS) which reported a 47% relative risk reduction for ipsilateral stroke or death in patients randomized to surgery compared to best medical management over 5 years. These data were further substantiated by the recent publication of the Medical Research Council Asymptomatic Carotid Surgery (ACST) trial results (1); however, both trials estimated that at least 40 operative procedures were required to prevent a single disabling stroke or death in one patient after 5 years (2). These data underscore the importance of understanding the cognitive risks of carotid revascularization and developing strategies to limit factors that contribute to this risk especially in asymptomatic patients.

The purpose of this study is to better understand the effect of carotid revascularization (using either carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS)) on cognitive outcome by prospectively collecting cerebral blood flow data and cognitive testing data prior to and after carotid revascularization procedures.

Studietype

Observasjonsmessig

Registrering (Forventet)

Kontakter og plasseringer

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

Studiesteder

Forente stater
- Massachusetts
  - Burlington, Massachusetts, Forente stater, 01805
    - Lahey Clinic, Inc.
- New York
  - Buffalo, New York, Forente stater, 14203
    - University of Buffalo Neurosurgery (UBNS)
  - Stony Brook, New York, Forente stater, 11794-8122
    - StonyBrook

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

Sannsynlighetsprøve

Studiepopulasjon

Patients with unilateral, asymptomatic, significant carotid artery stenosis who are ≥18 years of age who do not present with past or current significant cerebrovascular and neuropsychological disease.

Beskrivelse

Inclusion Criteria:

Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)

Exclusion Criteria:

Patients with prior large vessel infarct
Patients with intracranial stenosis
Patients with major depression
Patients with Alzheimer disease (clinically defined or Wechsler IQ <80)
Patients who have had previous ipsilateral carotid surgery
Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).

Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Carotid Endarterectomy (CEA) Surgical Revascularization- Carotid Endarterectomy (CEA)
Carotid Angioplasty and Stenting (CAS) Surgical Revascularization- Carotid Angioplasty and Stenting (CAS)
Control Group- Medical Management

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively. Tidsramme: preoperative/baseline and 1 month postoperative/from baseline	Quantitative flow MRA studies will be performed pre-operative and postoperative for those undergoing carotid revascularization surgery. Those not undergoing surgery will have this test upon study enrollment and approximately 1 month from study enrollment date.	preoperative/baseline and 1 month postoperative/from baseline

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Mini Mental Status Exam Tidsramme: Pre-operative/baseline	A standardized cognitive measure	Pre-operative/baseline
Trail Making- Part A Tidsramme: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized cognitive measure that assesses verbal fluency	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
Trail Making- Part B Tidsramme: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized cognitive measure that assesses executive functioning	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
Hopkins Verbal Learning Test (HVLT) Tidsramme: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized measure to assess new learning and memory	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
D-KEFS Verbal Fluency Test (FAS) Tidsramme: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline	Standardized measure to assess letter fluency	Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline

Samarbeidspartnere og etterforskere

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

Sponsor

Lahey Clinic

Etterforskere

Hovedetterforsker: Zoher Ghogawala, MD, Lahey Clinic, Inc.

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. april 2014

Primær fullføring (Faktiske)

1. november 2019

Studiet fullført (Faktiske)

1. november 2019

Datoer for studieregistrering

Først innsendt

15. april 2014

Først innsendt som oppfylte QC-kriteriene

16. april 2014

Først lagt ut (Anslag)

21. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. november 2019

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

2013-009

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. .