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CompletedNCT02756429REMI-2Updated Feb 22, 2018

Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation

An interventional study of blood samples in Atrial Fibrillation, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact on the general morbidity and risk of stroke, AF is a great concern for public health. Several mechanisms, including endothelial dysfunction and inflammatory processes, have been postulated as predisposing factors for AF, as well as for stroke.

Both clinical and experimental studies highlight inflammation as a predisposing factor for AF and its complications. Nevertheless, the source of high inflammatory proteins in patients with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation in AF patients.

The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also help to define the site of endothelial dysfunction and of production of this thrombogenic factor.

Although AF is associated with an increased risk of stroke, the risk is not homogeneous. Permanent and persistent AF are associated with similar thromboembolic risk to that of paroxysmal AF.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • atrial fibrillation
  • stroke
  • thromboembolism
  • inflammation
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 200 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient for which an electrophysiology exploration or ablation is programmed;
  • Patient who have given written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women;
  • lung disease history (all sources);
  • inflammatory disease history (all types);
  • Anti-inflammatory treatment;
  • left ventricular ejection fraction \<35%;
  • history of stroke;
  • Participation in other ongoing clinical trial.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    atrial fibrillation

    Patients with atrial fibrillation

    Other: blood samples

  • Experimental
    Control

    Patients without atrial fibrillation

    Other: blood samples

Interventions

  • Otherblood samples

    Patients with atrial fibrillation for whom electrophysiology exploration or ablation are programmed; All blood samples will be taken through the exploration catheter. For the peripheral blood sample, blood will be taken at the introduction of the catheter into the femoral vein. Then the blood samples in the coronary sinus and in the left atrium will be made at progressively exploration.

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What researchers measure

Primary outcomes

  1. VEGF concentration

    Concentration for VEGF between the peripheral blood and the samples collected from the coronary sinus or the left atrium, as well as a possible difference among patients with paroxysmal AF and those with persistent A. These assays will be carried out by an ELISA technique

    Time frame: Day one

  2. vWF concentration

    Concentration for vWF between the peripheral blood and the samples collected from the coronary sinus or the left atrium, as well as a possible difference among patients with paroxysmal AF and those with persistent A. These assays will be carried out by an ELISA technique

    Time frame: Day one

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Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69500, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02756429
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 29, 2016
Start date
Feb 2014
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Feb 22, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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