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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Enrolling

Conditions

Ischemic Stroke

Treatments

Procedure: transthoracic echocardiography
Other: Collection of clinical and radiological data
Other: 72-hour continuous Holter-ECG recording
Biological: standard biology
Biological: determination of serum GDF-15, osteoprotegerin and ST-2
Procedure: Electrocardiogram
Biological: Ultrasensitive Troponin-Ic

Study type

Interventional

Funder types

Other

Identifiers

NCT05683873
BEJOT ANR 2019

Details and patient eligibility

About

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)

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Yannick BEJOT

Data sourced from clinicaltrials.gov

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