Atrial Fibrillation and Characterization of Blood Platelet

Not Applicable

Terminated

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

• Registration Number: NCT02817815
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-29
• Study Start: 2016-11-02
• Primary Completion: 2018-10-26
• Study Completion: 2018-10-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Electrocardiogram (ECG)	Volunteers
Group 2	Blood sampling from the femoral vein	Paroxysmal AF patients in sinus rhythm the day of inclusion
Group 1	Blood sampling from the cephalic vein	Volunteers
Group 2	First blood sampling from left atrium	Paroxysmal AF patients in sinus rhythm the day of inclusion
Group 4	Atrial stimulation	Persistent AF patients in sinus rhythm the day of inclusion
Group 4	Blood sampling from the femoral vein	Persistent AF patients in sinus rhythm the day of inclusion
Group 4	Second blood sampling from left atrium	Persistent AF patients in sinus rhythm the day of inclusion
Group 5	Blood sampling from the femoral vein	Persistent AF patients in atrial fibrillation the day of inclusion
Group 2	Second blood sampling from left atrium	Paroxysmal AF patients in sinus rhythm the day of inclusion
Group 3	First blood sampling from left atrium	Paroxysmal AF patients in atrial fibrillation the day of inclusion
Group 3	Blood sampling from the femoral vein	Paroxysmal AF patients in atrial fibrillation the day of inclusion
Group 4	First blood sampling from left atrium	Persistent AF patients in sinus rhythm the day of inclusion
Group 2	Atrial stimulation	Paroxysmal AF patients in sinus rhythm the day of inclusion
Group 5	First blood sampling from left atrium	Persistent AF patients in atrial fibrillation the day of inclusion

Primary Outcome Measures

Name	Time	Method
Measure of maximal aggregation level (expressed in aggregation percentage) after ex vivo stimulation by Adenosine Di-Phosphate (ADP), arachidonic acid, ristocetin, collagen and Thrombin Receptor Activating Peptide (TRAP-6mers)	Day 1	Aggregation percentage is measured by the method of light transmission aggregometry
Measure of maximal disaggregation level (expressed in disaggregation percentage)	Day 1	Disaggregation percentage is measured by the method of light transmission aggregometry
Measure of platelet volume mean	Day 1
Assessment of the Platelet morphology (shape change)	Day 1
Assessment of the modification of the membrane receptor expression modification	Day 1
Identification of platelet proteins differentially expressed between groups	Day 1

Secondary Outcome Measures

Name	Time	Method
Measure of Tissue Factor (TF) dependent microparticles level	Day 1
Measure of fibrinolytic microparticles level	Day 1

Trial Locations

Locations (1)

Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque; 🇫🇷 Pessac, France