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| Name | Class |
|---|---|
| University Hospital, Marseille, France | UNKNOWN |
| Hospices Civils de Lyon, France | UNKNOWN |
| Centre Francois Baclesse, Caen, France | UNKNOWN |
| University Hospital of Saint-Etienne, France |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| occurence of atrial fibrillation | Other | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a cancer will defined as patients with confirmed cancer other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia.
Active cancer will be defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, and an anticancer treatment given at the time of enrollment or during 6 months before enrollment (according to Agnelli et al. NEJM 2020).
AF patients will be both patients with incident AF (first AF episode diagnosed after cancer diagnosis) and those with prevalent AF (AF recurrence occurring after cancer diagnosis and a first AF episode prior to cancer diagnosis)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Alexandre, MD, PhD | Contact | +330231064770 | alexandre-j@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Joachim Alexandre, MD, PhD | Caen Normandy University Hospital, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandre | Recruiting | Caen | Normandy | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29698683 | Background | Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24. | |
| 32353110 | Background | Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UNKNOWN |
| Hôpital Lariboisière Fernand Widal, Paris, France | UNKNOWN |
| Institut de Cancérologie de l'Ouest Nantes, France | UNKNOWN |
| Fundacion Cardio Onco, Santiago, Chile | UNKNOWN |
| University of Newcastle, Australia | OTHER |
| University Hospital, Rouen | OTHER |
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| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |