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

Assessment of the Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Young Subjects Victims of Cryptogenic Ischemic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Apnea Syndrome
• Intervention / Treatment: Diagnostic test: systematic etiological

Detailed Description

Obstructive sleep apnea syndrome (OSAS) and patent foramen ovale (PFO) are considered as risk factors for stroke. In most cases, the presence of FOP has no clinical impact. Certain hemodynamic conditions inducing a right-left pressure gradient can promote the reopening of a FOP and allow the passage of blood, presenting micro or macro-thrombi, from the venous system to the arterial system, explaining the mechanism of paradoxical embolism. 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. Evidence of a clinically significant interaction and causation in the genesis of stroke remains limited. More researches are needed in this area to confirm this complex association and its role in triggering stroke.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Theses following tests are made as usual practice : Ventilator polygraphy, or polysomnography between 1 month and 1 year after cryptogenic ischemic stroke.; Transoesophageal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of foramen oval	Presence of a foramen oval on transoesophageal ultrasound during the etiological assessment of the stroke.	1 year after the ischemic stoke

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean-Philippe CAMDESSANCHE, MD PhD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: obstructive sleep apnea syndrome; permeable foramen oval
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Congenital Abnormalities; Signs and Symptoms, Respiratory; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Stroke; Sleep Apnea Syndromes; Syndrome; Ischemic Stroke; Apnea; Foramen Ovale, Patent
• Other Study ID Numbers: IRBN212021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No