Clinical trial NCT02817815: Atrial Fibrillation and Characterization of Blood Platelet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation, blood platelet
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Day 1
measure: Measure of maximal disaggregation level (expressed in disaggregation percentage)
timeFrame: Day 1
measure: Measure of platelet volume mean
timeFrame: Day 1
measure: Assessment of the Platelet morphology (shape change)
timeFrame: Day 1
measure: Assessment of the modification of the membrane receptor expression modification
timeFrame: Day 1
measure: Identification of platelet proteins differentially expressed between groups
timeFrame: Day 1
Secondary outcomes:
measure: Measure of Tissue Factor (TF) dependent microparticles level
timeFrame: Day 1
measure: Measure of fibrinolytic microparticles level
timeFrame: Day 1
Other outcomes:
Locations:
city: Pessac
country: France
facility: Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque
Study officials:
References: