Comparing cardiovascular events in stroke patients with and without sleep-disordered breathing
Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke
This study is trying to see if having sleep-disordered breathing affects the risk of heart and brain problems in stroke patients over the next year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1620 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT04399200 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have experienced a first stroke or TIA within 72 hours and have a modified Rankin Scale score of 1 or less prior to the event.
Not a fit: Patients with a history of stroke, ongoing treatment for sleep-disordered breathing, or those unable to follow rehabilitation procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for stroke patients with sleep-disordered breathing, potentially reducing the risk of subsequent cardiovascular events.
How similar studies have performed: While there have been studies examining the relationship between sleep-disordered breathing and cardiovascular events, this specific approach of comparing SDB and non-SDB patients post-stroke is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Grenoble
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.