Ischemic Cerebrovascular Accident Clinical Trial
— SAFASOfficial title:
Stepwise Screening for Silent Atrial Fibrillation After Stroke
| NCT number | NCT03570060 |
| Other study ID # | GUENANCIA 2017 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2018 |
| Est. completion date | April 2025 |
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | April 2025 |
| Est. primary completion date | April 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon Bourgogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke. | 6 months |
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