Biological Bank for Atrial Fibrillation and Stroke (BAFA)

April 16, 2024 updated by: Hospices Civils de Lyon

Biological Bank for Studies Related to Atrial Fibrillation and Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bourg-en-Bresse, France, 01000
        • Recruiting
        • Service neurologie Centre hospitalier Fleyriat
        • Contact:
        • Principal Investigator:
          • Frédéric PHILIPPEAU, PH
      • Bron, France, 69677
        • Recruiting
        • Service d'urgences Neurovasculaires - service de neurologie vasculaire , Hôpital Pierre Wertheimer
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura MECHTOUFF, PH
        • Sub-Investigator:
          • Lucie RASCLE, MD,PhD
      • Bron, France, 69677
        • Recruiting
        • Service de rythmologie, hôpital cardiologique Louis Pradel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe CHEVALIER, PU-PH
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Service de médecine gériatrique Centre hospitalier Lyon Sud, Groupement hospitalier Sud
        • Contact:
        • Principal Investigator:
          • Marc BONNEFOY, PU-PH
      • Villeurbanne, France, 69100
        • Recruiting
        • Hopital des Charpennes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre Krolak-Salmon, PU,PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Atrial fibrillation patient Stroke patient Patient over 80

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1a
Patient with atrial fibrillation and without stroke history.
Biological: Blood taken
Collection of clinical data
Genetic: Blood taken
Collection of DNA
Genetic: Blood taken
Collection of plasma
Group 1b
Patient with atrial fibrillation with scheduled electrophysiology exploration or ablation.
Biological: Blood taken
Collection of clinical data
Genetic: Blood taken
Collection of DNA
Genetic: Blood taken
Collection of plasma
Group 1c
Patient with atrial fibrillation and with stroke history.
Biological: Blood taken
Collection of clinical data
Genetic: Blood taken
Collection of DNA
Genetic: Blood taken
Collection of plasma
Group 2
Patients aged over 80 years old and without history of atrial fibrillation.
Biological: Blood taken
Collection of clinical data
Genetic: Blood taken
Collection of DNA
Genetic: Blood taken
Collection of plasma
Group 3
Patient with cryptogenic stroke history before the age of 50.
Biological: Blood taken
Collection of clinical data
Genetic: Blood taken
Collection of DNA
Genetic: Blood taken
Collection of plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of DNA sample
Time Frame: 1 day (the day of the storage)
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)
Quality of Plasma sample
Time Frame: 1 day (the day of the storage)
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)
Quality of preservation of the sample
Time Frame: 7 years (during all the duration of the collection)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Estimated)

April 23, 2029

Study Completion (Estimated)

April 23, 2029

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0538
  • 2017-A03327-46 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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