Biological Bank for Atrial Fibrillation and Stroke

Stroke Clinical Trial

— BAFA  

Official title:

Biological Bank for Studies Related to Atrial Fibrillation and Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611816
• Other study ID #: 69HCL17_0538
• Secondary ID: 2017-A03327-46
• Status: Recruiting
• Start date: April 23, 2018
• Est. completion date: April 23, 2029

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Philippe CHEVALIER, PU-PH
• Phone: 04 72 35 70 27
• Email: philippe.chevalier[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: April 23, 2029
• Est. primary completion date: April 23, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Group 1a:

• Inclusion Criteria :

• Atrial Fibrillation history

• Exclusion Criteria :

• No Atrial Fibrillation history

• patient who didn't signed consent

Group 1b

• Inclusion Criteria :

• Atrial Fibrillation history

• Scheduled electrophysiological exploration or Atrial Fibrillation ablation

• Exclusion Criteria :

• No Atrial Fibrillation history

• pregnant women

• patient who didn't signed consent

Group 1c

• Inclusion Criteria :

• Atrial Fibrillation history

• Stroke history

• Exclusion Criteria :

• patient who didn't signed consent

Group 2

• Inclusion Criteria :

• patient over 80

• Electrocardiography : sinusal rhythm

• Transthoracic echocardiogram : no left atrial dilatation

• Exclusion Criteria :

• atrial fibrillation history

• Transthoracic echocardiogram : Left atria >25cm², > 34m/m2), LVEF (left ventricular ejection fraction) < 50%

• Electrocardiography : QRS > 90 ms

• cardiac pathologies (excepted hypertension and valvulopathies)

• History of stroke and transient ischemic attack

• patient who didn't signed consent

Group 3

• Inclusion Criteria :

• cryptogenic stroke history before 50 yo

• No Atrial Fibrillation history

• Exclusion Criteria :

• Atrial Fibrillation history

• stroke over 50 yo

• patient who didn't signed consent

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Biological:
• Blood taken
Collection of clinical data

Genetic:
• Blood taken
Collection of DNA
• Blood taken
Collection of plasma

Locations

Country	Name	City	State
France	Service neurologie Centre hospitalier Fleyriat	Bourg-en-Bresse
France	Service d'urgences Neurovasculaires - service de neurologie vasculaire , Hôpital Pierre Wertheimer	Bron
France	Service de rythmologie, hôpital cardiologique Louis Pradel	Bron
France	Service de médecine gériatrique Centre hospitalier Lyon Sud, Groupement hospitalier Sud	Pierre-Bénite
France	Hôpital des charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of DNA sample	Quality is based on the measure of the purity of DNA with absorbance assay at 260/280nm on a spectrophotometer. For Plasma sample, purity is based on absence of hemolyzed blood by visual observation.	1 day (the day of the storage)
Primary	Quality of Plasma sample	Quality is based on the purity of Plasma sample that is based on absence of hemolyzed blood by visual observation.	1 day (the day of the storage)
Primary	Quality of preservation of the sample	The quality of preservation of the sample throughout the conservation duration is based on the number of freezing/thawing of each cryotube that will be notified. As weel as any interruption in the freezing process (power failure, freezer failure).	7 years (during all the duration of the collection)