NCT07624396

Brief Summary

Atrial fibrillation (AF) is associated with serious complications, including embolic strokes, heart failure, and mortality. Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, increases the risk of thrombus formation. Once dislodged from the atrial cavity and traveling to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for atrial cardiomyopathy (ACM) and AF are metabolic syndrome and aging. ACM is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, the investigators aim to address this challenge by examining ACM through the lens of one of its complications: cardioembolic stroke. BDNF (Brain-Derived Neurotrophic Factor) is a neurotrophic factor involved in inflammatory and metabolic processes that may play a key role in the development of these complications. This study explores the association between circulating levels of BDNF and the morphological and metabolic characteristics of ACM, as assessed by cardiac and brain imaging studies

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
61mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jun 2031

First Submitted

Initial submission to the registry

April 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

5 years

First QC Date

April 17, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of cardioembolic stroke according to the TOAST classification, adjudicated with a blinded review of biomarker data by the treating of a neurologist upon the patient' s hospital discharge.

    At hospital discharge (approximately 5 to 10 day after admission)

Study Arms (1)

Patient who has suffered an acute ischemic stroke

Patient diagnosed with acute ischemic stroke based on brain imaging

Biological: Circulating BDNF levels measured via blood sample

Interventions

Diagnosis of cardioembolic stroke according to the TOAST13 classification, adjudicated with a blinded review of biomarker data by the treating of a neurologist upon the patient' s hospital discharge

Patient who has suffered an acute ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A patient diagnosed with acute ischemic stroke, confirmed by brain imaging (CT or MRI).

You may qualify if:

  • Individuals who provided informed consent
  • Diagnosis of acute ischemic stroke confirmed by brain imaging (CT or MRI)
  • Underwent a combined cardiac and brain CT scan within 24 hours of admission for stroke

You may not qualify if:

  • A person subject to a legal protective measure (guardianship, conservatorship)
  • A person subject to a judicial safeguard measure
  • A pregnant woman, a woman who has recently given birth, or a breastfeeding woman
  • An adult who is legally incapacitated or unable to give consent,
  • A minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected and processed to obtain serum. Serum sample will be aliquoted and stored for analysis of circulating protein biomarkers, including BDNF, osteoprotegerin, galectin-3, BMP-10, and PR pro-ANP. No genetic analyses will be performed.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

June 3, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

June 3, 2026

Record last verified: 2026-06

Locations