Ischemic StrokeSMOG-15NCT05683873
Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
An observational study of Ischemic Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Electrocardiogram, transthoracic echocardiography and standard biology
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2023to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospitalized for acute symptomatic cerebral infarction
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Yannick BEJOT, 0380293753, yannick.bejot@chu-dijon.fr
About this study
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.
Read more
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)
- Conditions
- Ischemic Stroke
- Being tested
- Electrocardiogram, transthoracic echocardiography, standard biology, determination of serum GDF-15, osteoprotegerin and ST-2, Ultrasensitive Troponin-Ic
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramProcedure or surgery
Inclusion visit, V1, V2 and V3
transthoracic echocardiographyProcedure or surgery
V1, V2 and V3
standard biologyBiological
Inclusion visit
determination of serum GDF-15, osteoprotegerin and ST-2Biological
Inclusion visit, V1, V2 and V3
Ultrasensitive Troponin-IcBiological
Inclusion visit, V1, V2 and V3
Collection of clinical and radiological dataOther
Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data
72-hour continuous Holter-ECG recordingOther
V1
| Study group | Role | What they receive |
|---|---|---|
| Acute symptomatic cerebral infarction | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)
Measured: within 24 to 72 hours post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start13 Feb 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683873
- Sponsor's protocol ID
- BEJOT ANR 2019
- Acronym
- SMOG-15
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data that underlie the results reported in this study, along with the study protocol and statistical analysis plan, will be available from the corresponding author (yannick.bejot@chu-dijon.fr) upon reasonable request. Data will be shared with qualified researchers following approval of a sound scientific proposal by the sponsor and investigators and the execution of a data-sharing agreement compliant with the EU General Data Protection Regulation (GDPR) and the French Data Protection Act. Data permitting the re-identification of participants will not be shared.