RecruitingNot ApplicableNCT05683873

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


Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

130 participants

Start Date

Feb 13, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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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


Locations(1)

Chu Dijon Bourgogne

Dijon, France

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NCT05683873


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