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NCT Number: NCT05683873

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

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)

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocardiogram

Procedure

Inclusion visit, V1, V2 and V3

Transthoracic echocardiography

Procedure

V1, V2 and V3

standard biology

Biological

Inclusion visit

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

Biological

Inclusion visit, V1, V2 and V3

Ultrasensitive Troponin-Ic

Biological

Inclusion visit, V1, V2 and V3

Collection of clinical and radiological data

Other

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

72-hour continuous Holter-ECG recording

Other

V1

Primary outcomes

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

    Time frame: within 24 to 72 hours post-stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Yannick BEJOT

CONTACT

[email protected]

0380293753

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: SMOG-15

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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