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

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ClinicalTrials.gov Identifier: NCT04846205
Recruitment Status : Enrolling by invitation
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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.

Condition or disease Intervention/treatment
Apnea Syndrome Stroke 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 Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of the Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Young Subjects Victims of Cryptogenic Ischemic Stroke
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Apnea hypopnea index [ Time Frame: 1 year after the ischemic stoke ]
    Apnea Hypopnea Index (AHI) > 15 / h on ventilator polygraphy (PV), or AHI >10/h on polysomnography (PSG) will be considered as a risk factor


Secondary Outcome Measures :
  1. Presence of foramen oval [ Time Frame: 1 year after the ischemic stoke ]
    Presence of a foramen oval on transoesophageal ultrasound during the etiological assessment of the stroke.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846205


Locations
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France
CHU de Saint-Etienne
Saint-Étienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Jean-Philippe CAMDESSANCHE, MD PhD CHU de Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04846205    
Other Study ID Numbers: IRBN212021/CHUSTE
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
obstructive sleep apnea syndrome
permeable foramen oval
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Stroke
Ischemic Stroke
Foramen Ovale, Patent
Syndrome
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities