Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Victims of Cryptogenic Ischemic Stroke

NCT04846205 | Completed

• 1 other identifier: IRBN212021/CHUSTE
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea syndrome (OSAS) and patent foramen ovale (FOP) are considered as risk factors for stroke. OSAS generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of right-left shunt embolus and therefore the risk of stroke. OSA and FOP are often thought as two separate entities, however, due to their high frequencies, they sometimes coexist and can influence the pathophysiology of each other. More researches are needed in this area to confirm this complex association and its role in triggering stroke.

Conditions

Apnea Syndrome; Stroke

Keywords

obstructive sleep apnea syndrome; permeable foramen oval

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index

  Apnea Hypopnea Index (AHI) \> 15 / h on ventilator polygraphy (PV), or AHI \>10/h on polysomnography (PSG) will be considered as a risk factor

  1 year after the ischemic stoke

Secondary Outcomes (1)

• Presence of foramen oval

  1 year after the ischemic stoke

Study Arms (1)

Patients who underwent a systematic etiological

Patients who underwent a systematic etiological assessment in the context of their cryptogenic ischemic stroke between 2015 and 2020. A collect data in medical record will be realized.

Diagnostic Test: systematic etiological

Interventions

systematic etiological DIAGNOSTIC_TEST

Theses following tests are made as usual practice : * Ventilator polygraphy, or polysomnography between 1 month and 1 year after cryptogenic ischemic stroke. * Transoesophageal ultrasound

Patients who underwent a systematic etiological

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a systematic etiological assessment in the context of their cryptogenic ischemic stroke between 2015 and 2020.

You may qualify if:

• \- Patients who have had a cerebral or retinal infarction confirmed by brain imaging or a defined transient ischemic attack without an identifiable cause after a detailed etiological assessment

You may not qualify if:

• Identification of a cause of ischemic stroke:
• Atheromatous stenosis \> 50% (or atherosclerotic plaque \< 50% threatening) of supra aortic trunk or intracranial arteries on echodoppler of the supra aortic trunk and transcranial or scanner angiography.
• Emboligenic heart disease : atrial fibrillation and atrial flutter, thrombus in left atrium, spontaneous contrast in left atrium, decreased atrial flow, left ventricular ejection fraction (LVEF) \< 40%, LV aneurysma, left intraventricular thrombus, recent myocardial infarction, cardiomyopathy ventricular dilated left with LVEF \< 35%, mitral stenosis, prosthetic mitral or aortic valve, infectious and non-infectious endocarditis, valve or mural tumor, complicated aortic arch atheroma (plaque \> = 4 mm, ulcerated plaque, thrombus on plaque), aortic dissection
• Lacunar infarction symptomatic = \< 1.5 cm on the CT scan, = \< 2 cm on the diffusion MRI or the FLAIR.
• No atherosclerotic arteriopathy : dissection, primary and secondary angitis, spastic angiopathy, etc…
• Coagulopathy to come a long-term anticoagulant treatment (\> 6 months) (anti-phospholipid syndrome, thrombophilia).
• Blood disorders and cancer
• Recent intravenous drug use (in the 6 months before the stroke).
• Other potential causes:
• Severe respiratory impairment or pulmonary arterial hypertension

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stroke; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Philippe CAMDESSANCHE, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: March 24, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)