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

NCT ID: NCT05683873

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocardiogram

Inclusion visit, V1, V2 and V3

Intervention Type PROCEDURE

transthoracic echocardiography

V1, V2 and V3

Intervention Type PROCEDURE

standard biology

Inclusion visit

Intervention Type BIOLOGICAL

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

Inclusion visit, V1, V2 and V3

Intervention Type BIOLOGICAL

Ultrasensitive Troponin-Ic

Inclusion visit, V1, V2 and V3

Intervention Type BIOLOGICAL

Collection of clinical and radiological data

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

Intervention Type OTHER

72-hour continuous Holter-ECG recording

V1

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yannick BEJOT

Role: CONTACT

0380293753

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yannick BEJOT

Role: primary

0380293753

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BEJOT ANR 2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Automatic PredICtion of Edema After Stroke
NCT04057690 ACTIVE_NOT_RECRUITING