Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package

Study Overview
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Brief Summary
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The aim of this study is to analyze the relationship between the blood biomarker GDF-15 and heart damage after stroke. It is being conducted in France, in the Neurology Department of the Dijon University Hospital (Burgundy). The research is interventional because a biological blood test will be performed, as well as a heart rhythm recording and several cardiac echograms during the hospitalization of the participants and during the follow-up consultation scheduled 4 to 6 months after the stroke. A total of 130 stroke patients will participate in this study. Participation includes 4 visits: Inclusion visit (within 24 hours of the first stroke symptoms) visit 1 (within 24 to 72 hours of stroke) visit 2 (within 48 hours of visit 1) Visit 3 (approximately 4-6 months post-stroke)

Official Title
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Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: Electrocardiogram
* Procedure: transthoracic echocardiography
* Biological: standard biology
* Biological: determination of serum GDF-15, osteoprotegerin and ST-2
* Biological: Ultrasensitive Troponin-Ic
* Other: Collection of clinical and radiological data
* Other: 72-hour continuous Holter-ECG recording


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult with acute symptomatic cerebral infarction documented by brain imaging on admission (cerebral angioscan or cerebral MRI) Whose first symptoms appeared within 24 hours before inclusion Whose consent to participate in this study was obtained from the patient or a close relative. Exclusion Criteria: Person with a history of symptomatic stroke, either ischemic or hemorrhagic Anyone with a history of heart disease including: atrial fibrillation or flutter (known or discovered on admission), chronic heart failure, pacemaker, defibrillator, or other cardiac devices Person with acute heart failure, suspected infective endocarditis, STEMI, or concurrent pulmonary embolism A person who is not a member or beneficiary of a social security system Person deprived of liberty Person subject to a legal protection measure (curatorship, guardianship) Person subject to a legal protection measure Pregnant, parturient or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Electrocardiogram|Inclusion visit, V1, V2 and V3|
|Procedure: transthoracic echocardiography|V1, V2 and V3|
|Biological: standard biology|Inclusion visit|
|Biological: determination of serum GDF-15, osteoprotegerin and ST-2|Inclusion visit, V1, V2 and V3|
|Biological: Ultrasensitive Troponin-Ic|Inclusion visit, V1, V2 and V3|
|Other: Collection of clinical and radiological data|Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data|
|Other: 72-hour continuous Holter-ECG recording|V1|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE) |  | within 24 to 72 hours post-stroke |