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Search / Trial NCT04399200

Apnea, Stroke and Incident Cardiovascular Events

Launched by UNIVERSITY HOSPITAL, GRENOBLE · May 18, 2020

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Stroke Sleep Disordered Breathing Cardio Vascular Events Atherosclerosis

ClinConnect Summary

This clinical trial is studying how sleep-disordered breathing (SDB) affects the risk of heart and brain events after a stroke or transient ischemic attack (TIA), which is sometimes called a mini-stroke. The researchers want to see if patients with SDB, which includes conditions like obstructive sleep apnea, have more complications, like heart attacks or strokes, one year after their initial stroke compared to those without SDB. The study will include 1,620 patients who have had a stroke or TIA, and they will be monitored for several years.

To be eligible for this study, participants should be between 18 and 85 years old, must have experienced their first stroke or a TIA, and need to have a good functional status before the stroke. They must also be willing to provide consent to participate. Throughout the study, participants can expect to undergo various tests, including sleep studies, to diagnose SDB and regular follow-ups to track their heart and brain health. It's important to know that this study will help researchers understand the impact of sleep-related issues on recovery after a stroke, which could lead to better care for future patients.

Gender

ALL

Eligibility 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

About University Hospital, Grenoble

The University Hospital of Grenoble is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. As a prominent sponsor of clinical trials, the hospital leverages its expertise in various medical disciplines to facilitate cutting-edge studies that aim to improve treatment outcomes and enhance patient safety. With a strong commitment to collaboration, the University Hospital of Grenoble engages in partnerships with academic institutions, industry leaders, and regulatory bodies to drive scientific discovery and translate research findings into clinical practice. Its state-of-the-art facilities and multidisciplinary teams ensure rigorous adherence to ethical standards and regulatory guidelines, fostering an environment where groundbreaking research can thrive.

Locations

Grenoble, , France

Patients applied

0 patients applied

Trial Officials

Renaud Tamisier, MD, PhD, MBA

Principal Investigator

University Hospital, Grenoble

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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