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OpenTrials
Completed

NCT Number: NCT03570060

Stepwise Screening for Silent Atrial Fibrillation After Stroke

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.

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Key information

Conditions

Ischemic Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: SAFAS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2018
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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