SAFAS: Stepwise Screening for Silent Atrial Fibrillation After Stroke

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03570060
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Cerebrovascular Accident	Biological: Blood sample; Procedure: Long term ECG monitor; Procedure: Monitoring ECG

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Stepwise Screening for Silent Atrial Fibrillation After Stroke
• Actual Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Outcome Measures

Primary Outcome Measures

1. Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03570060
• Other Study ID Numbers: GUENANCIA 2017
• First Posted: Jun 26, 2018
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Atrial Fibrillation

Study Results

No Results Posted as of Apr 22, 2021