NCT04399200Recruiting
Apnea, Stroke and Incident Cardiovascular Events
Sleep Apnea Syndrome and Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCEs) After a First Stroke
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease. 1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort. Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) \> 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1620 (estimated)
- First submitted
- 25 Mar 2020
- Start date
- 13 Jul 2020
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Stroke
- NCT number
- NCT04399200
What you commit to
- Study type: Observational
- Planned participants: 1620
- From 13 Jul 2020 to the primary completion date, 1 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Past history of stroke
Other
- Pregnant or breastfeeding women
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| university Hospital Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.