Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02817815
Other study ID # CHUBX 2015/21
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A