Comparing cardiovascular events in stroke patients with and without sleep-disordered breathing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort study aims to evaluate the incidence of cardiac and cerebrovascular events in patients who have experienced a first stroke or transient ischemic attack (TIA) and have been diagnosed with sleep-disordered breathing (SDB). The study will include 1620 patients, who will undergo polysomnography three months after their cerebrovascular event to determine SDB status based on an Apnea-Hypopnea Index (AHI) greater than 15 events/hour. The primary outcome will assess the occurrence of major adverse cardiovascular events, including death from cardiac or cerebrovascular causes, non-fatal strokes, and non-fatal acute coronary events, one year after SDB diagnosis. Secondary outcomes will include various clinical and cognitive assessments over a five-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 to 85 years
* Admitted in the stroke unit no later than 72h after the onset of stroke symptoms:

  * First stroke confirmed by computed tomography scan or magnetic resonance imaging, whatever the localization
  * Initial or recurrent TIA, as defined by a brief and sudden neurological dysfunction for which an ischemic cause is presumed, with symptoms lasting less than 24 hours, and/or with no visible lesion on neuroimaging evaluation.
* Score on the Modified Ranking scale (mRS) ≤1 before stroke
* Signed informed consent by patient or his/her relative if not able
* Patient eligible to carotid endarterectomy (for ancillary study only)

Exclusion Criteria:

* Pregnant or breastfeeding women
* Past history of stroke
* Inability to follow rehabilitation procedure
* Patients with ongoing treatment for SDB
* Exclusion period for another study
* Patients not affiliated to a French social and health insurance system or equivalent
* Prisoners or patients who require protection by the law

Where it's running

• University Hospital Grenoble
  Grenoble, France Recruiting

Study contacts

• Principal investigator: Renaud Tamisier, MD, PhD, MBA — University Hospital, Grenoble
• Study coordinator: Sébastien Baillieul, MD, MSc
• Email: sbaillieul@chu-grenoble.fr
• Phone: +33 (0)4 76 76 75 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.