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Clinical Trials/NCT05683873
NCT05683873RecruitingNot Applicable

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

Centre Hospitalier Universitaire Dijon2 sites in 1 country130 target enrollmentStarted: February 13, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
130
Locations
2
Primary Endpoint
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)

Time Frame: within 24 to 72 hours post-stroke

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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