Atrial Fibrillation and Characterization of Blood Platelet (FAPS)

University Hospital of Bordeaux

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Biological: Second blood sampling from left atrium; Device: Electrocardiogram (ECG); Biological: First blood sampling from left atrium; Biological: Blood sampling from the cephalic vein; Biological: Blood sampling from the femoral vein; Procedure: Atrial stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02817815

CHUBX 2015/21

Details and patient eligibility

About

Arterial thromboembolism constitutes a major risk of atrial fibrillation (AF) requiring antithrombotic therapy. Platelets and microparticles (MPs) are important for hemostasis and thrombosis, their role during AF is not well known. The principal objective of this study is to compare morphologic, functional and proteomics characteristics of blood platelet between AF patients and healthy volunteers.

Full description

AF is associated with decreased quality of life and an increased risk of thromboembolic events. AF is the leading cause of embolic stroke. Identification of factors that may influence blood coagulability in these patients could better identify therapeutic targets to optimize anticoagulation. Platelets play a major role in the coagulation process, their study may provide valuable information. Moreover microparticles from platelet activation are known to have pathophysiological effects including effects on thrombosis and inhibition of fibrinolysis. It has also been shown that the microparticles have a role in endothelial dysfunction and generation of inflammatory condition which are associated with atrial fibrillation.

Investigators propose in this project, a comparative study between AF patients and healthy volunteers. Complete characterization of platelet (morphology, platelet function, platelet proteome) and microparticles levels will be perform. Different site blood sampling (systemic or cardiac) will be done in patients during their ablation procedure. Patients will be followed during their hospitalisation.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Inclusion Criteria: valid for all groups

  • Age superior or equal to 18 years old, both genders.
  • Patient affiliated or recipient of a social welfare regimen.
  • Patient's write agreement for study participation after reading information note

• Inclusion Criteria: specific for groups

Group 1:

• Volunteers without heart disease.
• Volunteers who never had AF and not in AF the day of inclusion. Group 2
• Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient in sinus rhythm the day of inclusion. Group 3
• Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient in atrial fibrillation the day of inclusion Group 4
• Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient in sinus rhythm the day of inclusion. Group 5
• Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient in atrial fibrillation the day of inclusion

Exclusion criteria

• Age <18 years.
• Active smoker (> 10 cigarettes/days)
• Pregnant woman or breastfeeding women or not receiving effective contraception.
• Volunteer participating in another interventional study requiring taking drug.
• Volunteer having taken antinflammatory, platelet anti-aggregant or calcium-channel blocker drugs within 8 days prior to inclusion
• Valvular heart diseases.
• Chronic inflammatory diseases.
• Cardiovascular event or stroke within 3 month prior to inclusion
• Uncontrolled hypertension
• Chronic hepatic or renal diseases.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 5 patient groups

Group 1

Active Comparator group

Description:

Volunteers

Treatment:

Device: Electrocardiogram (ECG)

Biological: Blood sampling from the cephalic vein

Group 2

Experimental group

Description:

Paroxysmal AF patients in sinus rhythm the day of inclusion

Treatment:

Biological: First blood sampling from left atrium

Biological: Second blood sampling from left atrium

Procedure: Atrial stimulation

Biological: Blood sampling from the femoral vein

Group 3

Experimental group

Description:

Paroxysmal AF patients in atrial fibrillation the day of inclusion

Treatment:

Biological: First blood sampling from left atrium

Biological: Blood sampling from the femoral vein

Group 4

Experimental group

Description:

Persistent AF patients in sinus rhythm the day of inclusion

Treatment:

Biological: First blood sampling from left atrium

Biological: Second blood sampling from left atrium

Procedure: Atrial stimulation

Biological: Blood sampling from the femoral vein

Group 5

Experimental group

Description:

Persistent AF patients in atrial fibrillation the day of inclusion

Treatment:

Biological: First blood sampling from left atrium

Biological: Blood sampling from the femoral vein