FAPS: Atrial Fibrillation and Characterization of Blood Platelet
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 Volunteers |
Device: Electrocardiogram (ECG)
Biological: Blood sampling from the cephalic vein
|
| Experimental: Group 2 Paroxysmal AF patients in sinus rhythm the day of inclusion |
Biological: Blood sampling from the femoral vein
Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
Biological: First blood sampling from left atrium
Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
Procedure: Atrial stimulation
Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF
Biological: Second blood sampling from left atrium
After 20min of continuous AF, a blood sampling from left atrium will be done
|
| Experimental: Group 3 Paroxysmal AF patients in atrial fibrillation the day of inclusion |
Biological: Blood sampling from the femoral vein
Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
Biological: First blood sampling from left atrium
Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
|
| Experimental: Group 4 Persistent AF patients in sinus rhythm the day of inclusion |
Biological: Blood sampling from the femoral vein
Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
Biological: First blood sampling from left atrium
Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
Procedure: Atrial stimulation
Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF
Biological: Second blood sampling from left atrium
After 20min of continuous AF, a blood sampling from left atrium will be done
|
| Experimental: Group 5 Persistent AF patients in atrial fibrillation the day of inclusion |
Biological: Blood sampling from the femoral vein
Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
Biological: First blood sampling from left atrium
Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
|
Outcome Measures
Primary Outcome Measures
- 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
- Measure of Tissue Factor (TF) dependent microparticles level [Day 1]
- Measure of fibrinolytic microparticles level [Day 1]
Eligibility Criteria
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:
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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
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Valvular heart diseases.
-
Chronic inflammatory diseases.
-
Cardiovascular event or stroke within 3 month prior to inclusion
-
Uncontrolled hypertension
-
Chronic hepatic or renal diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque | Pessac | France | 33604 |
Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX 2015/21