Atrial Fibrillation and Characterization of Blood Platelet

Atrial Fibrillation Clinical Trial

— FAPS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02817815
• Other study ID #: CHUBX 2015/21
• Status: Terminated
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: October 26, 2018

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Electrocardiogram (ECG)

Biological:
• Blood sampling from the cephalic vein

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

Locations

Country	Name	City	State
France	Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Aggregation percentage is measured by the method of light transmission aggregometry	Day 1
Primary	Measure of maximal disaggregation level (expressed in disaggregation percentage)	Disaggregation percentage is measured by the method of light transmission aggregometry	Day 1
Primary	Measure of platelet volume mean		Day 1
Primary	Assessment of the Platelet morphology (shape change)		Day 1
Primary	Assessment of the modification of the membrane receptor expression modification		Day 1
Primary	Identification of platelet proteins differentially expressed between groups		Day 1
Secondary	Measure of Tissue Factor (TF) dependent microparticles level		Day 1
Secondary	Measure of fibrinolytic microparticles level		Day 1