Atrial Fibrillation and Characterization of Blood Platelet (FAPS)

February 9, 2022 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1
Measure of maximal disaggregation level (expressed in disaggregation percentage)
Time Frame: Day 1
Disaggregation percentage is measured by the method of light transmission aggregometry
Day 1
Measure of platelet volume mean
Time Frame: Day 1
Day 1
Assessment of the Platelet morphology (shape change)
Time Frame: Day 1
Day 1
Assessment of the modification of the membrane receptor expression modification
Time Frame: Day 1
Day 1
Identification of platelet proteins differentially expressed between groups
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of Tissue Factor (TF) dependent microparticles level
Time Frame: Day 1
Day 1
Measure of fibrinolytic microparticles level
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2016

Primary Completion (ACTUAL)

October 26, 2018

Study Completion (ACTUAL)

October 26, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Electrocardiogram (ECG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe