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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05683873
Acronym
SMOG-15
Enrollment
130
Registered
2023-01-13
Start date
2023-02-13
Completion date
2027-08-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief 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). 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

PROCEDUREElectrocardiogram

Inclusion visit, V1, V2 and V3

PROCEDUREtransthoracic echocardiography

V1, V2 and V3

BIOLOGICALstandard biology

Inclusion visit

BIOLOGICALdetermination of serum GDF-15, osteoprotegerin and ST-2

Inclusion visit, V1, V2 and V3

BIOLOGICALUltrasensitive Troponin-Ic

Inclusion visit, V1, V2 and V3

OTHERCollection of clinical and radiological data

Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data

OTHER72-hour continuous Holter-ECG recording

V1

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)within 24 to 72 hours post-stroke

Countries

France

Contacts

Primary ContactYannick BEJOT
yannick.bejot@chu-dijon.fr0380293753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026