Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrocardiogram, transthoracic echocardiography, standard biology, determination of serum GDF-15, osteoprotegerin and ST-2.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Interventions
- 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
Primary outcome measures
- Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE) [Time frame: within 24 to 72 hours post-stroke]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Chu Dijon Bourgogne — Dijon
Identifiers
NCT: NCT05683873 · BEJOT ANR 2019