Atrial Fibrillation and Characterization of Blood Platelet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-02

Study Completion Date

2018-10-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Volunteers

Group Type ACTIVE_COMPARATOR

Electrocardiogram (ECG)

Intervention Type DEVICE

Blood sampling from the cephalic vein

Intervention Type BIOLOGICAL

Group 2

Paroxysmal AF patients in sinus rhythm the day of inclusion

Group Type EXPERIMENTAL

Blood sampling from the femoral vein

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter

First blood sampling from left atrium

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction

Atrial stimulation

Intervention Type PROCEDURE

Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF

Second blood sampling from left atrium

Intervention Type BIOLOGICAL

After 20min of continuous AF, a blood sampling from left atrium will be done

Group 3

Paroxysmal AF patients in atrial fibrillation the day of inclusion

Group Type EXPERIMENTAL

Blood sampling from the femoral vein

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter

First blood sampling from left atrium

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction

Group 4

Persistent AF patients in sinus rhythm the day of inclusion

Group Type EXPERIMENTAL

Blood sampling from the femoral vein

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter

First blood sampling from left atrium

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction

Atrial stimulation

Intervention Type PROCEDURE

Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF

Second blood sampling from left atrium

Intervention Type BIOLOGICAL

After 20min of continuous AF, a blood sampling from left atrium will be done

Group 5

Persistent AF patients in atrial fibrillation the day of inclusion

Group Type EXPERIMENTAL

Blood sampling from the femoral vein

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter

First blood sampling from left atrium

Intervention Type BIOLOGICAL

Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction

Interventions

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Electrocardiogram (ECG)

Intervention Type DEVICE

Blood sampling from the cephalic vein

Intervention Type BIOLOGICAL

Blood sampling from the femoral vein

Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter

Intervention Type BIOLOGICAL

First blood sampling from left atrium

Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction

Intervention Type BIOLOGICAL

Atrial stimulation

Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF

Intervention Type PROCEDURE

Second blood sampling from left atrium

After 20min of continuous AF, a blood sampling from left atrium will be done

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes