Back to resultsAtrial Fibrillation and Characterization of Blood Platelet (FAPS)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrocardiogram (ECG)
Blood sampling from the cephalic vein
Blood sampling from the femoral vein
First blood sampling from left atrium
Atrial stimulation
Second blood sampling from left atrium
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation focused on measuring Atrial fibrillation, blood platelet
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
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.
Sites / Locations
- Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Arm Description
Volunteers
Paroxysmal AF patients in sinus rhythm the day of inclusion
Paroxysmal AF patients in atrial fibrillation the day of inclusion
Persistent AF patients in sinus rhythm the day of inclusion
Persistent AF patients in atrial fibrillation the day of inclusion
Outcomes
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)
Aggregation percentage is measured by the method of light transmission aggregometry
Measure of maximal disaggregation level (expressed in disaggregation percentage)
Disaggregation percentage is measured by the method of light transmission aggregometry
Measure of platelet volume mean
Assessment of the Platelet morphology (shape change)
Assessment of the modification of the membrane receptor expression modification
Identification of platelet proteins differentially expressed between groups
Secondary Outcome Measures
Measure of Tissue Factor (TF) dependent microparticles level
Measure of fibrinolytic microparticles level
Full Information
NCT ID
NCT02817815
First Posted
June 22, 2016
Last Updated
February 9, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02817815
Brief Title
Atrial Fibrillation and Characterization of Blood Platelet
Acronym
FAPS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Departure and non-replacement of the person in charge of the biological examinations specific to research carried out within the LIRYC IHU.
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, blood platelet
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Volunteers
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Paroxysmal AF patients in sinus rhythm the day of inclusion
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Paroxysmal AF patients in atrial fibrillation the day of inclusion
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Persistent AF patients in sinus rhythm the day of inclusion
Arm Title
Group 5
Arm Type
Experimental
Arm Description
Persistent AF patients in atrial fibrillation the day of inclusion
Intervention Type
Device
Intervention Name(s)
Electrocardiogram (ECG)
Intervention Type
Biological
Intervention Name(s)
Blood sampling from the cephalic vein
Intervention Type
Biological
Intervention Name(s)
Blood sampling from the femoral vein
Intervention Description
Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
Intervention Type
Biological
Intervention Name(s)
First blood sampling from left atrium
Intervention Description
Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
Intervention Type
Procedure
Intervention Name(s)
Atrial stimulation
Intervention Description
Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF
Intervention Type
Biological
Intervention Name(s)
Second blood sampling from left atrium
Intervention Description
After 20min of continuous AF, a blood sampling from left atrium will be done
Primary Outcome Measure Information:
Title
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)
Description
Aggregation percentage is measured by the method of light transmission aggregometry
Time Frame
Day 1
Title
Measure of maximal disaggregation level (expressed in disaggregation percentage)
Description
Disaggregation percentage is measured by the method of light transmission aggregometry
Time Frame
Day 1
Title
Measure of platelet volume mean
Time Frame
Day 1
Title
Assessment of the Platelet morphology (shape change)
Time Frame
Day 1
Title
Assessment of the modification of the membrane receptor expression modification
Time Frame
Day 1
Title
Identification of platelet proteins differentially expressed between groups
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Measure of Tissue Factor (TF) dependent microparticles level
Time Frame
Day 1
Title
Measure of fibrinolytic microparticles level
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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.
Facility Information:
Facility Name
Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
12. IPD Sharing Statement
Learn more about this trial
Atrial Fibrillation and Characterization of Blood Platelet
We'll reach out to this number within 24 hrs