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Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation (REMI-2)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, thromboembolism, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

atrial fibrillation

Control

Arm Description

Patients with atrial fibrillation

Patients without atrial fibrillation

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2016
Last Updated
February 19, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02756429
Brief Title
Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation
Acronym
REMI-2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, stroke, thromboembolism, inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atrial fibrillation
Arm Type
Experimental
Arm Description
Patients with atrial fibrillation
Arm Title
Control
Arm Type
Experimental
Arm Description
Patients without atrial fibrillation
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
VEGF concentration
Description
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
Title
vWF concentration
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient for which an electrophysiology exploration or ablation is programmed; Patient who have given written informed consent. 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.
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation

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