Stepwise Screening for Silent Atrial Fibrillation After Stroke

NCT03570060 | Completed

• 1 other identifier: GUENANCIA 2017
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke.

  6 months

Interventions

Blood sample BIOLOGICAL

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

Long term ECG monitor PROCEDURE

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

Monitoring ECG PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (2)

• 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.

  PMID: 37429637 DERIVED

• 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.

  PMID: 35911547 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 26, 2018
• Study Start: April 1, 2018
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

FR (1)