AzTrials
AzTrials

Atrial FibrillationFAPSNCT02817815

Atrial Fibrillation and Characterization of Blood Platelet

A study testing Electrocardiogram (ECG), Blood sampling from the cephalic vein and Blood sampling from the femoral vein in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
What is being tested?
Electrocardiogram (ECG), Blood sampling from the cephalic vein and Blood sampling from the femoral vein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteFrance
Study dates
2 Nov 2016to 26 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Volunteers who never had AF and not in AF the day of inclusion. Group 2
Show all 14Show fewer
  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • Chronic inflammatory diseases.
  • Cardiovascular event or stroke within 3 month prior to inclusion
  • Uncontrolled hypertension
  • Chronic hepatic or renal diseases.

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Pessac, 33604

Other trials in France

About this study

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.

Read the 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.

Being tested
Electrocardiogram (ECG), Blood sampling from the cephalic vein, Blood sampling from the femoral vein, First blood sampling from left atrium, Atrial stimulation
Keywords
Atrial fibrillation, blood platelet
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrocardiogram (ECG)Device

  • Blood sampling from the cephalic veinBiological

  • Blood sampling from the femoral veinBiological

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

  • First blood sampling from left atriumBiological

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

  • Atrial stimulationProcedure or surgery

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

  • Second blood sampling from left atriumBiological

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

Study groups in NCT02817815
Study groupRoleWhat they receive
Group 1Active comparatorVolunteers
Receives: Device: Electrocardiogram (ECG); Biological: Blood sampling from the cephalic vein
Group 2ExperimentalParoxysmal AF patients in sinus rhythm the day of inclusion
Receives: 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 3ExperimentalParoxysmal AF patients in atrial fibrillation the day of inclusion
Receives: Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium
Group 4ExperimentalPersistent AF patients in sinus rhythm the day of inclusion
Receives: 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 5ExperimentalPersistent AF patients in atrial fibrillation the day of inclusion
Receives: Biological: Blood sampling from the femoral vein; Biological: First blood sampling from left atrium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. Measure of maximal disaggregation level (expressed in disaggregation percentage)

    Disaggregation percentage is measured by the method of light transmission aggregometry

    Measured: Day 1

  3. Measure of platelet volume mean

    Measured: Day 1

  4. Assessment of the Platelet morphology (shape change)

    Measured: Day 1

  5. Assessment of the modification of the membrane receptor expression modification

    Measured: Day 1

  6. Identification of platelet proteins differentially expressed between groups

    Measured: Day 1

Secondary outcomes (2)

  1. Measure of Tissue Factor (TF) dependent microparticles level

    Measured: Day 1

  2. Measure of fibrinolytic microparticles level

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start2 Nov 2016
  3. Primary completion26 Oct 2018
  4. Study completion26 Oct 2018

Why it stopped: Departure and non-replacement of the person in charge of the biological examinations specific to research carried out within the LIRYC IHU.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817815
Sponsor's protocol ID
CHUBX 2015/21
Acronym
FAPS
Status last verified
Feb 2022
First submitted
22 Jun 2016
Last updated
28 Feb 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrocardiogram (ECG), Blood sampling from the cephalic vein and Blood sampling from the femoral vein in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Departure and non-replacement of the person in charge of the biological examinations specific to research carried out within the LIRYC IHU.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in