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Stroke Interventions in Clinical Trials
Printable Version
ACES
Asymptomatic Carotid Emboli Study



Principal Investigator
Hugh Markus, FRCP

PI Address
Prof. Hugh Markus
Centre for Clinical Neuroscience
St George’s University of London
Cranmer Terrace
London SW17 0RE
Tel: 44 (0) 20 8725 2735
Email: h.markus@sgul.ac.uk

Contact Address
Alice King
Centre for Clinical Neuroscience
St George’s University of London
Cranmer Terrace
London
SW17 0RE
Tel: 44 (0) 20 8725 0961
Fax: 44 (0) 20 8725 2950
Email: acestrial@sgul.ac.uk

Contact Email
acestrial@sgul.ac.uk

Sponsor



Study Size Actual:482
Study Size Planned:480
Centers Actual:31
Follow-up Duration:2 Years
Status:
Completed. Results published October 2009.

Purpose:
To determine whether asymptomatic emboli detected in the middle cerebral artery are an independent predictor of stroke and TIA risk in patients with asymptomatic carotid stenosis.

Location(s):
Croatia, France, Georgia, Germany, Hong Kong, Ireland, Israel, Italy, Lithuania, Netherlands, Singapore, Slovenia, Spain, United Kingdom, United States.

Year Started: 2000
Year Finished: 2007
Year Presented: 2010
Year Published: 2010


Design:
Multicenter, prospective study.

Inclusion Criteria
Patients with 70-99% asymptomatic carotid stenosis determined by duplex ultrasound criteria, asymptomatic in the relevant carotid artery territory for two years or longer, free of symptoms in the contralateral carotid artery or vertebro-basilar territories for more than two years.

Exclusion Criteria
Concurrent disease likely to limit life expectancy to <3 years.

Patient Involvement:
At enrollment, subjects will have two single one-hour transcranial Doppler recordings from the ipsilateral middle cerebral artery, separated by approximately one week. Clinical data, a standardised carotid duplex examination recorded onto videotape, and CT scan (where possible) will also be performed. In selected centres, carbon dioxide reactivity to 6% CO2 or acetazolamide will be performed at entry only. Clinical follow-up will be performed at six months, twelve months, eighteen months and twenty-four months and in addition patients will be assessed following any TIA’s or strokes. Additional transcranial Doppler recordings will be performed for one hour from the ipsilateral middle cerebral artery at six months, twelve months and eighteen months.

Primary Outcome:
Combined endpoint of ipsilateral stroke and transient ischaemic attack in the territory of the asymptomatic carotid stenosis.

Results:
Recruitment was completed in October 2007 with 482 subjects. At the baseline, the proportion of subjects with embolic signals was 10.7% on recording 1, 10.8% on recording 2 and 16.7% on either of the two recordings. Embolic signal prevalence on the two recordings was significantly associated (chi(2) 27.48, P<0.0005). Patients without embolic signals were more likely to be treated with antiplatelets (90.8 vs 76.9%, P<0.0005) and this difference persisted on multivariate analysis. In conclusion, Asymptomatic Carotid Emboli Study will determine whether embolic signal is a useful predictor in asymptomatic carotid stenosis, and detection allows its predictive value to be compared with clinical features, imaging parameters and ultrasound plaque morphology. Baseline data show antiplatelet therapy is associated with fewer embolic signals.

Source of Information:
Stroke. 2004 35: e359 - e368.
ACES Web Site.
Poster presented October 2006 at the 5th Annual Symposium Cardiovascular Research Group in UK.
Abstract presented International Stroke Conference (February 2008).
Presented at the 2010 ESC [May 2010].

Web Links and Publications:
Effects of intensive medical therapy on microemboli and cardiovascular risk in asymptomatic carotid stenosis.
Arch Neurol 2010 Feb;67(2):180-6

Asymptomatic embolisation for prediction of stroke in the Asymptomatic Carotid Emboli Study (ACES): a prospective observational study
Lancet Neurology

The Asymptomatic Carotid Emboli Study: study design and baseline results.
Int J Stroke 2009 Oct;4(5):398-405

St. George's University in London

This information last updated on: 6/18/2010

Reviewed on: 06/03/2010.

UID: 529

   

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