Atrial Fibrillation in Active Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.

Official Title
-----------------
Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients

Conditions
-----------------
Cancer, Drug Toxicity, Atrial Fibrillation, Cardiovascular Complication

Intervention / Treatment
-----------------
* Other: occurence of atrial fibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients outpatients or hospitalized patients with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment) at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis) in sinus rhythm at the time of cancer diagnosis Exclusion Criteria: patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence) history of long-standing persistant or permanent AF prior to cancer diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: occurence of atrial fibrillation|all adult patients with an active cancer and experiencing atrial fibrillation will be consecutively include. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major cardiovascular events and death of any cause at 1 year | Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation. | from inclusion in the registry to 1 year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients | Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients according to the AF type (prevalent or incident). | from inclusion in the registry to 1 year of follow-up | 
| Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients). | Description of the population of active cancer patients experiencing atrial fibrillation. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607). | at the inclusion in the registry | 
| Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients). | Description of the management (anticoagulants, rhythm or rate control) of atrial fibrillation in cancer patients | from inclusion in the registry to 1 year of follow-up | 
| Description of the population of active cancer patients having a major cardiovascular event | Description of the population of patients having a major cardiovascular event among cancer patients experiencing atrial fibrillation | from inclusion in the registry to 1 year of follow-up | 
| Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence | Identifying risk factors (clinical, EKG, biological, echocardiography) of major cardiovascular events and all cause mortality in cancer patients experiencing atrial fibrillation | from inclusion in the registry to 1 year of follow-up | 
| Identifying factors associated with atrial fibrillation recurrence | Identifying factors (clinical, EKG, biological, echocardiography) of atrial fibrillation recurrence in cancer patients | from inclusion in the registry to 1 year of follow-up | 
| Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition) | Occurrence of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation. | from inclusion in the registry to 1 year of follow-up | 
| Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition) | Identifying risk factors (clinical, EKG, biological, echocardiography) of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation | from inclusion in the registry to 1 year of follow-up |