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

Ischemic Stroke Clinical Trial

— SMOG-15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683873
• Other study ID #: BEJOT ANR 2019
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: August 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Yannick BEJOT
• Phone: 0380293753
• Email: yannick.bejot[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Electrocardiogram
Inclusion visit, V1, V2 and V3
• transthoracic echocardiography
V1, V2 and V3

Biological:
• standard biology
Inclusion visit
• determination of serum GDF-15, osteoprotegerin and ST-2
Inclusion visit, V1, V2 and V3
• Ultrasensitive Troponin-Ic
Inclusion visit, V1, V2 and V3

Other:
• Collection of clinical and radiological data
Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data
• 72-hour continuous Holter-ECG recording
V1

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)		within 24 to 72 hours post-stroke