Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
SMOG-15
1 other identifier
interventional
130
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedStudy Start
First participant enrolled
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
January 28, 2025
January 1, 2025
4.5 years
January 2, 2023
January 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)
within 24 to 72 hours post-stroke
Interventions
Inclusion visit, V1, V2 and V3
V1, V2 and V3
Inclusion visit
Inclusion visit, V1, V2 and V3
Inclusion visit, V1, V2 and V3
Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data
Eligibility Criteria
You may qualify if:
- Adult with acute symptomatic cerebral infarction documented by brain imaging on admission (cerebral angioscan or cerebral MRI)
- Whose consent to participate in this study was obtained from the patient or a close relative.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, 21000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 13, 2023
Study Start
February 13, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
January 28, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share