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Atrial Fibrillation and Characterization of Blood Platelet

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02817815
Acronym
FAPS
Enrollment
86
Registered
2016-06-29
Start date
2016-11-02
Completion date
2018-10-26
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, blood platelet

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.

Interventions

BIOLOGICALBlood sampling from the cephalic vein
BIOLOGICALBlood sampling from the femoral vein

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

BIOLOGICALFirst blood sampling from left atrium

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

PROCEDUREAtrial stimulation

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

BIOLOGICALSecond blood sampling from left atrium

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of platelet proteins differentially expressed between groupsDay 1
Assessment of the Platelet morphology (shape change)Day 1
Assessment of the modification of the membrane receptor expression modificationDay 1
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 1Aggregation percentage is measured by the method of light transmission aggregometry
Measure of maximal disaggregation level (expressed in disaggregation percentage)Day 1Disaggregation percentage is measured by the method of light transmission aggregometry
Measure of platelet volume meanDay 1

Secondary

MeasureTime frame
Measure of fibrinolytic microparticles levelDay 1
Measure of Tissue Factor (TF) dependent microparticles levelDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026