Track topics on Twitter Track topics that are important to you
The aim of the present prospective study is to further develop and validate a composite risk score predicting both ischemic and bleeding risk, based on epidemiologic, clinical, biological, and/or morphologic complementary data. First, the investigators will assess the predictive performance of current clinical risk scores. Second, the investigators will assess the potential predictive value of additional markers. Third, the investigators will aim to develop a new risk score.
Patients with Atrial Fibrillation (AF) have an excessive risk of arterial thromboembolic disease and heart failure, resulting in higher rates of cardiovascular and all-cause mortality in this population.
Prevalence and incidence of Non-Valvular AF (NVAF) is rapidly increasing across developed countries. cardiovascular (CV) and all-cause mortality rates related to AF have increased between 1990 and 2010, irrespective of sex.
Determinants of AF (heart disease and/or cardiovascular risk factors), are themselves associated with an excess risk of cardiovascular events.
Primary prevention of NVAF relies on the control of modifiable risk factors, such as overweight, arterial hypertension, diabetes, and tobacco consumption which are associated with the risk of AF risk and its complications.
Preventive treatment of cardiovascular complications is based on anti-thrombotic treatment, which reduces the global ischemic risk but at the expense of an increase of bleeding risk.
Treatment decisions are guided by the evaluation of ischemic and hemorrhagic risks, as determined by clinical scores (like CHADS2; CHA2DS2-VASc; HAS-BLED) that have been validated on varying populations through retrospective cohort studies. However, since their publication, these clinical scores have been criticized regarding their predictive value, the lack of precision in the definition of their component and the threshold defined for treatment decisions. Furthermore, several studies have demonstrated the interest of biomarkers in addition to clinical parameters to predict the risk of cardiovascular complications in AF. For example, preliminary data suggest that the dosage of Brain-type natriuretic peptide (BNP), N-terminal (NT) Pro-BNP, troponin, C-reactive protein (CRP), and all indicators whose levels increase independently of their usual causes may contribute to a better prediction of cardiovascular complications including all-cause mortality in NVAF. Of note, the rate of major bleeding events was very low (1.5 per cent among 3,978 patients from the Euro Heart Survey on AF with complete follow-up) in the HAS-BLED validation cohort.
We hypothesize that epidemiologic, clinical, biologic, and morphologic complimentary data could improve the stratification of cardiovascular risk in NVAF. Biologic and echocardiographic approaches, in particular, could improve the performance of routinely used clinical scores. Consequently, identification of a state of inflammation, hypercoagulability, or increased circulating concentrations of certain biomarkers could explain the increased risk of cardiovascular events in AF. Furthermore, the morphologic repercussions of NVAF, including left atrium dilation and left ventricular systolic dysfunction, as well as the presence of left atrial appendage stasis indicators, could also help refine the risk stratification.
In a previous retrospective survey, the investigators have shown that biomarkers and echomarkers could better stratify AF patients at increased cardiovascular risk. However, due to its retrospective design and the lack of completeness, the investigators could not validate a new risk score including all these markers and taking into account both thromboembolic and hemorrhagic risk. Indeed, these usual biologic and morphologic parameters will be obtained at admission in all patients in a prospective design.
There are three study sites.
Professor Ariel COHEN is the coordinating investigator of the study. A Clinical Research Associate working within the Cardiology Service of the Saint-Antoine Hospital will monitor the study.
The study duration is 5 years:
- Inclusion period: 3 years
- End of study: 2 years after the end of inclusion period
- Follow-up: the follow-up period will run for 2 years.
Inclusion: The inclusion visit will occur during the patient's hospitalization for NVAF in the Cardiology Department. At the inclusion visit, information will be collected regarding the patient's history of clinical events, current risk factors and treatments.
Follow-up: After hospital discharge, each patient will be seen every six month throughout the two year follow-up period.
During the follow-up period, information on clinical events, changes in risk factors and treatments occurring since the last follow-up contact will be collected for each patient, a blood sample will be collected, and an echocardiography will be conducted.
Classification of preceding events and follow-up information will be supported by both clinical exams and medical file evaluation. Interviews with general practitioners and the patients themselves will also be used in order to collect all necessary information. In the event of hospitalization, hospitalization reports will be collected. In cases of events without hospitalization, general practitioner correspondence and prescription records will be collected.
Patients with NVAF will receive anti-thrombotic treatment, in accordance with routine care and European society of cardiology (ESC) guidelines.
The choice of anti-thrombotic treatment will be entirely at the discretion of the attending physician during hospitalization.
Information describing all treatments received by each patient will be collected throughout the study, from the inclusion visit to the final follow-up contact.
All echocardiographic procedures will be performed in the echocardiographic laboratory of each Cardiology Department. Cardiologists specialized in echocardiographic examination will perform all echocardiographic procedures.
Each participant will undergo an echocardiographic examination at their inclusion and at each follow-up visit occurring every 6 months. The objective of the echocardiographic examinations is the identification of cardiac conditions and diseases that may be associated with AF.
Primary Outcome variables The primary outcome variable is a composite cardiovascular endpoint including stroke, transitory ischemic attack, thromboembolism, acute heart failure, acute coronary syndrome, major bleeding and cardiovascular and all-cause mortality.
(Major bleeding will be defined according to international society on thrombosis and haemostasis (ISTH) criteria)
Secondary Outcome variables
The incidence of each of the following events will be determined:
- death (all-cause and cardiovascular)
- acute heart failure
- acute coronary syndrome
- major bleeding episodes
Enrolled participants will be included in the analysis. Participants who withdrew their consent will be excluded from any analysis. Participants who had no event or those who were lost to follow-up (impossibility of contact for more than 24 months) will be included up to the date of their last contact.
Event free survival is defined as the time period from the day of enrollment in the study to the day of the event or death.
Overall survival will be calculated for each patient starting at their enrollment until their death or the end of follow-up. One analysis per event type will be conducted.
One vital status research will be conducted for each participant lost to follow-up; where appropriate a cause of death research will be undertaken. To deal with the possibility for a same patient to present multiple events, we will consider competing risk models.
Observational Model: Cohort, Time Perspective: Prospective
Service de cardiologie - hôpital Saint Antoine
Saint Antoine University Hospital
Published on BioPortfolio: 2016-04-18T17:38:22-0400
Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation
Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with...
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
The objective of this registry is the characterization of patients with atrial fibrillation (AF) with confirmed valvular heart disease (VHD) who are prescribed edoxaban in a real-life clin...
ACS are a potent risk factor for AF, with new onset AF occurring in up to 1 in every 5 patients hospitalized with an ACS. Despite its relatively frequent occurrence and the many etiologic...
Deficiency of testosterone was associated with the susceptibility of atrial fibrillation. Angiotensin-II receptor antagonists were shown to reduce atrial fibrillation by improving atrial electrical re...
Radiofrequency ablation has become a safe and effective treatment for atrial fibrillation. We believe that referral to an electrophysiologist for consideration of ablation may allow for better rhythm ...
The aim of this study was to evaluate a spatial correlation between active atrial fibrillation (AF) drivers measured by ECGI and complex fractionated atrial electrograms (CFAEs) in patients with persi...
Recently, the analysis of the spatio-temporal behavior of atrial fibrillation activation patterns has been widely investigated with the aim to better understand the arrhythmia implications on the hear...
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Impaired or delayed impulse conduction between the right and left HEART ATRIA. Advanced interatrial blocks are often associated with arrhythmias (e.g., ATRIAL FLUTTER; and ATRIAL FIBRILLATION), direct conduction block via the Bachmann's bundle and concomitant left atrial enlargement. Syndrome of advanced interatrial block associated with SUPRAVENTRICULAR TACHYCARDIA is referred to as Bayes syndrome.
A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...
Complementary and Alternative Medicine
Alternative medicine are whole medical systems that did not fit with conventional medicine as they have completely different philosophies and ideas on the causes of disease, methods of diagnosis and approaches to treatment. Although often overlapping, co...
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example: to diagnose diseases to measure the progress or recovery from disease to confirm that a person is free from disease Clin...