Atrial Fibrillation and Characterization of Blood Platelet

NCT02817815 | Terminated

• 1 other identifier: CHUBX 2015/21
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, blood platelet

Outcome Measures

Primary Outcomes (6)

• 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

• Measure of maximal disaggregation level (expressed in disaggregation percentage)

  Disaggregation percentage is measured by the method of light transmission aggregometry

  Day 1

• Measure of platelet volume mean

  Day 1

• Assessment of the Platelet morphology (shape change)

  Day 1

• Assessment of the modification of the membrane receptor expression modification

  Day 1

• Identification of platelet proteins differentially expressed between groups

  Day 1

Secondary Outcomes (2)

• Measure of Tissue Factor (TF) dependent microparticles level

  Day 1

• Measure of fibrinolytic microparticles level

  Day 1

Study Arms (5)

Group 1

ACTIVE COMPARATOR

Volunteers

Device: Electrocardiogram (ECG); Biological: Blood sampling from the cephalic vein

Group 2

EXPERIMENTAL

Paroxysmal AF patients in sinus rhythm the day of inclusion

Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium; Procedure: Atrial stimulation; Biological: Second blood sampling from left atrium

Group 3

EXPERIMENTAL

Paroxysmal AF patients in atrial fibrillation the day of inclusion

Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium

Group 4

EXPERIMENTAL

Persistent AF patients in sinus rhythm the day of inclusion

Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium; Procedure: Atrial stimulation; Biological: Second blood sampling from left atrium

Group 5

EXPERIMENTAL

Persistent AF patients in atrial fibrillation the day of inclusion

Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium

Interventions

Electrocardiogram (ECG) DEVICE

Group 1

Blood sampling from the cephalic vein BIOLOGICAL

Group 1

Blood sampling from the femoral vein BIOLOGICAL

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

Group 2; Group 3; Group 4; Group 5

First blood sampling from left atrium BIOLOGICAL

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

Group 2; Group 3; Group 4; Group 5

Atrial stimulation PROCEDURE

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

Group 2; Group 4

Second blood sampling from left atrium BIOLOGICAL

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

Group 2; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Group 1:
• Volunteers without heart disease.
• Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.
• Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation.

You may not qualify if:

• 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.
• Valvular heart diseases.
• Chronic inflammatory diseases.
• Uncontrolled hypertension
• Chronic hepatic or renal diseases.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 29, 2016
• Study Start: November 2, 2016
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

FR (1)