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Clinical Trials/NCT02817815
NCT02817815
Terminated
Not Applicable

Atrial Fibrillation and Characterization of Blood Platelet

University Hospital, Bordeaux1 site in 1 country86 target enrollmentNovember 2, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University Hospital, Bordeaux
Enrollment
86
Locations
1
Primary Endpoint
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)
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2016
End Date
October 26, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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
  • 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.

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.

Outcomes

Primary Outcomes

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)

Time Frame: Day 1

Aggregation percentage is measured by the method of light transmission aggregometry

Measure of maximal disaggregation level (expressed in disaggregation percentage)

Time Frame: Day 1

Disaggregation percentage is measured by the method of light transmission aggregometry

Measure of platelet volume mean

Time Frame: Day 1

Assessment of the Platelet morphology (shape change)

Time Frame: Day 1

Assessment of the modification of the membrane receptor expression modification

Time Frame: Day 1

Identification of platelet proteins differentially expressed between groups

Time Frame: Day 1

Secondary Outcomes

  • Measure of Tissue Factor (TF) dependent microparticles level(Day 1)
  • Measure of fibrinolytic microparticles level(Day 1)

Study Sites (1)

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