Atrial FibrillationREMI-2NCT02756429
Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation
A study testing blood samples in people with Atrial Fibrillation, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient for which an electrophysiology exploration or ablation is programmed;
- Patient who have given written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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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.
- Conditions
- Atrial Fibrillation
- Being tested
- blood samples
- Keywords
- atrial fibrillation, stroke, thromboembolism, inflammation
- Medical subject headings
- Atrial Fibrillation, Stroke, Thromboembolism, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation | Experimental | Patients with atrial fibrillation Receives: Other: blood samples |
| Control | Experimental | Patients without atrial fibrillation Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day one
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
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756429
- Sponsor's protocol ID
- 2012-719
- Acronym
- REMI-2
- Status last verified
- Feb 2018
- First submitted
- 27 Apr 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02756429
- Acronym / sponsor ID
- REMI-2 / 2012-719
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, stroke, thromboembolism, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation | Experimental | Other: blood samplesPatients with atrial fibrillation |
| Control | Experimental | Other: blood samplesPatients without atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient for which an electrophysiology exploration or ablation is programmed;
- Patient who have given written informed consent.
Key exclusion criteria (7 listed)
- Pregnant women;
- lung disease history (all sources);
- inflammatory disease history (all types);
- Anti-inflammatory treatment;
- left ventricular ejection fraction <35%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesPatients 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. | Other | Control, atrial fibrillation |
Primary outcome
VEGF concentration
Time frame: Day one
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
Time frame: Day one
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Atrial Fibrillation, run by Hospices Civils de Lyon 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VEGF concentration (time frame: Day one). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.