Assessing bleeding and thromboembolic risks in patients with atrial fibrillation
Impact of Clinical, Echocardiographic and Biological Parameters to the Risk of Cardiovascular Disease in Patients With Non-valvular Atrial Fibrillation.
This study is trying to create a new risk score to help doctors better understand the chances of bleeding and blood clots in people with atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 825 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Antoine University Hospital Academic / other |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT02741349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a composite risk score that predicts both ischemic and bleeding risks in patients with non-valvular atrial fibrillation (NVAF). The researchers will first evaluate the predictive performance of existing clinical risk scores and then assess the potential value of additional markers. Ultimately, they aim to create a new risk score that could improve treatment decisions for patients with NVAF. The study will involve collecting epidemiologic, clinical, biological, and morphologic data from participants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with documented non-valvular atrial fibrillation.
Not a fit: Patients with significant valve disease or secondary atrial fibrillation due to acute causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate risk stratification and improved treatment strategies for patients with atrial fibrillation.
How similar studies have performed: Other studies have shown success in developing risk scores for atrial fibrillation, but this approach aims to refine and improve existing models.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults above 18 years of age * Presenting a NVAF which is paroxysmal, persistent or permanent and documented by an electrocardiogram (ECG) * Willing and able to give written informed consent Exclusion Criteria: * Patients presenting a clinically and echocardiographically significant valve disease defined as : * mitral stenosis with a valve area \< 2cm2 * mitral insufficiency (grade 3 or 4) * aortic insufficiency (grade 3 or 4) * tricuspid insufficiency (grade 3 or 4) * aortic stenosis with a valve area \< 1.5 cm2 * mechanical valve prosthèses * Secondary AF due to an acute cause (thyrotoxicosis, acute pericarditis, infection, systemic disease) * Presence of a contraindication to long term anticoagulant treatment * Absence of social security coverage * Severe psychiatric history * Impossibility of follow-up
Where this trial is running
Paris and 3 other locations
- Service de cardiologie - hôpital Saint Antoine — Paris, France (Recruiting)
- Service de cadiologie - Hôpital Pitié Salpêtrière — Paris, France (Suspended)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- Service de cardiologie - Clinique Pasteur — Toulouse, France (Suspended)
Study contacts
- Principal investigator: Ariel Cohen, Md, PhD — AP-HP, Hôpital Saint-Antoine, Service de cardiologie, 75012 Paris, France
- Study coordinator: Ariel Cohen, MD, PhD
- Email: ariel.cohen@aphp.fr
- Phone: +33149282886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.