Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— REMI-2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756429
• Other study ID #: 2012-719
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: February 19, 2018
• Start date: February 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• blood 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day one
Primary	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	Day one