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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrocardiogram
transthoracic echocardiography
standard biology
determination of serum GDF-15, osteoprotegerin and ST-2
Ultrasensitive Troponin-Ic
Collection of clinical and radiological data
72-hour continuous Holter-ECG recording
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 2, 2023
Last Updated
July 21, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05683873
Brief Title
Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
Acronym
SMOG-15
Official Title
Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Electrocardiogram
Intervention Description
Inclusion visit, V1, V2 and V3
Intervention Type
Procedure
Intervention Name(s)
transthoracic echocardiography
Intervention Description
V1, V2 and V3
Intervention Type
Biological
Intervention Name(s)
standard biology
Intervention Description
Inclusion visit
Intervention Type
Biological
Intervention Name(s)
determination of serum GDF-15, osteoprotegerin and ST-2
Intervention Description
Inclusion visit, V1, V2 and V3
Intervention Type
Biological
Intervention Name(s)
Ultrasensitive Troponin-Ic
Intervention Description
Inclusion visit, V1, V2 and V3
Intervention Type
Other
Intervention Name(s)
Collection of clinical and radiological data
Intervention Description
Inclusion visit, V1 and V3: clinical data only V2: clinical and radiological data
Intervention Type
Other
Intervention Name(s)
72-hour continuous Holter-ECG recording
Intervention Description
V1
Primary Outcome Measure Information:
Title
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)
Time Frame
within 24 to 72 hours post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick BEJOT
Phone
0380293753
Email
yannick.bejot@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick BEJOT
Phone
0380293753
Email
yannick.bejot@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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