Stepwise Screening for Silent Atrial Fibrillation After Stroke

NCT ID: NCT03570060

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-03-23

Brief Summary

The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.

Conditions

Ischemic Cerebrovascular Accident

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blood sample

2 ml of blood for testing for serum biomarkers (IL-6, GDF-15, soluble ST-2 soluble, osteoprotegerin, galectin 3)

Intervention Type: BIOLOGICAL

Long term ECG monitor

Fitting and removal of a long term ECG monitor (SpiderFlash, LivaNova)

Intervention Type: PROCEDURE

Monitoring ECG

Recording of automatic ECG monitor results (CSM Philips IntelliVue MP50 system)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient who had an ischemic stroke defined according to WHO criteria and hospitalized in the Stroke Unit at the Dijon University Hospital.
• Patient 18 years of age and older
• Patient who has given oral consent

Exclusion Criteria

• Person not affiliated to a national health insurance scheme
• Protected adult
• Pregnant or breastfeeding woman
• Patient refusing to participate in the study
• Transfer planned after the stay in the Stroke Unit to a department outside the Dijon University Hospital, not allowing for the long term screening with an external ECG monitor
• History of atrial fibrillation or atrial flutter
• Patient wearing a pacemaker or defibrillator with an atrial lead

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Countries

France

References

Didier R, Garnier L, Duloquin G, Meloux A, Sagnard A, Graber M, Dogon G, Benali K, Pommier T, Laurent G, Vergely C, Bejot Y, Guenancia C. Distribution of atrial cardiomyopathy markers and association with atrial fibrillation detected after ischaemic stroke in the SAFAS study. Stroke Vasc Neurol. 2024 Apr 30;9(2):165-173. doi: 10.1136/svn-2023-002447.

Reference Type: DERIVED

PMID: 37429637 (View on PubMed)

Garnier L, Duloquin G, Meloux A, Benali K, Sagnard A, Graber M, Dogon G, Didier R, Pommier T, Vergely C, Bejot Y, Guenancia C. Multimodal Approach for the Prediction of Atrial Fibrillation Detected After Stroke: SAFAS Study. Front Cardiovasc Med. 2022 Jul 13;9:949213. doi: 10.3389/fcvm.2022.949213. eCollection 2022.

Reference Type: DERIVED

PMID: 35911547 (View on PubMed)

Other Identifiers

GUENANCIA 2017

Identifier Type: -

Identifier Source: org_study_id