Clinical trial NCT03909386: Non-interventional Study on Patients With Atrial Fibrillation and Cancer
Official title: Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Cancer
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 1514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment) and with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.

Brief summary: AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified.

A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

Detailed description: International, multicenter, non-interventional study on patients with atrial fibrillation (AF) and cancer (diagnosed within the last 3 years prior to enrolment).

The study will be conducted in about 80 sites in italy and 50 sites distributed in other European countries (Belgium, Germany, Ireland, Portugal, Spain, The Netherlands, Turkey).

The study will continue till the consecutive recruitment of 1500 patients. The recruitment period will last approximately 24 months.

Number of visits per patient: Baseline and 1 year (Final). Physicians will not be required to perform any additional tests, assessments, etc., not in line with their routine medical practice.

Eligibility criteria: Inclusion Criteria:

* Both sexes
* Age \>18 years
* Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment)
* Patient with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.
* Written informed consent (IC) for participation in the study
* Patient not simultaneously participating in any interventional study.

Exclusion Criteria:

-

Primary outcomes:
measure: Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy
timeFrame: Baseline
measure: Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy
timeFrame: 12 Months
Secondary outcomes:
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death)
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy
timeFrame: Baseline and 12 months
measure: Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death
timeFrame: Baseline and 12 months
measure: Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes
timeFrame: Baseline and 12 months
measure: Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes
timeFrame: Baseline and 12 months
measure: Treatment satisfaction
timeFrame: Baseline and 12 months
measure: Quality of life satisfaction
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV ZIEKENHUIS AALST - Cardiology
city: Bonheiden
country: Belgium
facility: AZ IMELDA - Cardiology
city: Brugge
country: Belgium
facility: AZ ST-JAN - Cardiology
city: Brussels
country: Belgium
facility: Hôpital Erasme - Cardiology
city: Brussels
country: Belgium
facility: UCL Cliniques universitaires Saint-Luc - Cardiolgy
city: Brussel
country: Belgium
facility: UZ Brussel - Cardiology
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg - Cardiology
city: Hasselt
country: Belgium
facility: JESSA HASSELT - Cardiology
city: Kortrijk
country: Belgium
facility: AZ GROENINGE - Cardiology
city: Leuven
country: Belgium
facility: UZ LEUVEN - Cardiovascular diseases
city: Roeselare
country: Belgium
facility: AZ DELTA ROESELARE - Cardiology
city: Turnhout
country: Belgium
facility: AZ TURNHOUT - Cardiology
city: Cork
country: Ireland
facility: Bon Secours Hospital Cork - Oncology Department
city: Dublin
country: Ireland
facility: Beacon Hospital, Cardiology
city: Dublin
country: Ireland
facility: Tallaght University Hospital - Geriatric and Stroke Medicine Department
city: Agrigento
country: Italy
facility: Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic
state: AG
city: Canicattì
country: Italy
facility: Ospedale Barone Lombardo - Cardiologia E Utic
state: AG
city: Casale Monferrato
country: Italy
facility: Ospedale Santo Spirito - Sc Cardiologia
state: AL
city: Fabriano
country: Italy
facility: Ospedale Civile Profili - U.O. Cardiologia
state: AN
city: Arezzo
country: Italy
facility: Ospedale San Donato - U.O. Cardiologia
state: AR
city: Bari
country: Italy
facility: Ospedale San Paolo - Cardiologia-Utic
state: BA
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia
state: BA
city: Treviglio
country: Italy
facility: Ospedali Treviglio-Caravaggio - Cardiologia
state: BG
city: Belluno
country: Italy
facility: Ospedale Civile - Sc Cardiologia
state: BL
city: Feltre
country: Italy
facility: Ospedale Santa Maria Del Prato - U.O. Di Cardiologia
state: BL
city: Bologna
country: Italy
facility: Ospedale Maggiore - U.O. Di Cardiologia
state: BO
city: Bologna
country: Italy
facility: Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi
state: BO
city: Bologna
country: Italy
facility: Ospedale Bellaria - U.O. Di Cardiologia
state: BO
city: Cagliari
country: Italy
facility: Ospedale A. Businco - Servizio Di Cardiologia
state: CA
city: Cagliari
country: Italy
facility: Ospedale Roberto Binaghi - Servizio Di Cardiologia
state: CA
city: Caserta
country: Italy
facility: Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic
state: CE
city: Santa Maria Capua Vetere
country: Italy
facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
state: CE
city: Mondovì
country: Italy
facility: Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic
state: CN
city: Savigliano
country: Italy
facility: Ospedale Maggiore Ss. Annunziata - Sc Cardiologia
state: CN
city: Castrovillari
country: Italy
facility: Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic
state: CS
city: Paola
country: Italy
facility: Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia
state: CS
city: Catania
country: Italy
facility: P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
state: CT
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica
state: CT
city: Catania
country: Italy
facility: Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia
state: CT
city: Foggia
country: Italy
facility: Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
state: FG
city: Empoli
country: Italy
facility: Ospedale Civile San Giuseppe - Cardiologia
state: FI
city: Firenze
country: Italy
facility: Ospedale San Giovanni Di Dio - Cardiologia
state: FI
city: Firenze
country: Italy
facility: Aou Careggi - Cardiologa Diagnostica
state: FI
city: Firenze
country: Italy
facility: Aou Careggi - Diagnostica Cardiovascolare
state: FI
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari
state: GE
city: Genova
country: Italy
facility: Ospedale Padre Antero Micone - Sc Cardiologia - Utic
state: GE
city: Copertino
country: Italy
facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
state: LE
city: Scorrano
country: Italy
facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
state: LE
city: Lido Di Camaiore
country: Italy
facility: Nuovo Ospedale Versilia - Sc Cardiologia
state: LU
city: Messina
country: Italy
facility: Policlinico G. Martino - U.O. Medicina Interna
state: ME
city: Milano
country: Italy
facility: Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia
state: MI
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia - Cardiologia
state: MI
city: Milano
country: Italy
facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa
state: MI
city: Vizzolo Predabissi
country: Italy
facility: Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc
state: MI
city: Carpi
country: Italy
facility: Ospedale Ramazzini - U.O. Cardiologia
state: MO
city: Sassuolo
country: Italy
facility: Ospedale Di Sassuolo - Cardiologia
state: MO
city: Nuoro
country: Italy
facility: Ospedale San Francesco - Cardiologia - Utic
state: NU
city: Cefalù
country: Italy
facility: Fondazione G. Giglio - U.O. Cardiologia E Utic
state: PA
city: Palermo
country: Italy
facility: Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello
state: PA
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - Cardiologia Oncologica
state: PD
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica
state: PE
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello
state: PI
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico (Cro) - Cardiologia
state: PN
city: Pesaro
country: Italy
facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic
state: PU
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico San Matteo - Cardiologia
state: PV
city: Pavia
country: Italy
facility: Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica
state: PV
city: Ravenna
country: Italy
facility: Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia
state: RA
city: Polistena
country: Italy
facility: Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic
state: RC
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia
state: RC
city: Guastalla
country: Italy
facility: Ospedale Civile - Sc Cardiologia Area Nord
state: RE
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - S.C. Cardiologia
state: RE
city: Ragusa
country: Italy
facility: Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic
state: RG
city: Ariccia
country: Italy
facility: Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic
state: RM
city: Roma
country: Italy
facility: Campus Biomedico - Cardiologia
state: RM
city: Roma
country: Italy
facility: P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
state: RM
city: Roma
country: Italy
facility: Ospedale San Camillo - Uosd Servizi Cardiologici Integrati
state: RM
city: Roma
country: Italy
facility: Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia
state: RM
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.
state: RM
city: Riccione
country: Italy
facility: Ospedale G. Ceccarini - Cardiologia-Utic
state: RN
city: Salerno
country: Italy
facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva
state: SA
city: Poggibonsi
country: Italy
facility: Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic
state: SI
city: Sarzana
country: Italy
facility: Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa
state: SP
city: Augusta
country: Italy
facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
state: SR
city: Castellaneta
country: Italy
facility: Ospedale Di Castellaneta - S.C. Cardiologia
state: TA
city: Manduria
country: Italy
facility: Ospedale Civile M. Giannuzzi - Cardiologia E Utic
state: TA
city: Martina Franca
country: Italy
facility: Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia
state: TA
city: Teramo
country: Italy
facility: Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica
state: TE
city: Rovereto
country: Italy
facility: Ospedale Santa Maria Del Carmine - Cardiologia
state: TN
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
state: TO
city: Pinerolo
country: Italy
facility: Ospedale Civile E. Agnelli - Sc Di Cardiologia
state: TO
city: Rivoli
country: Italy
facility: Ospedale Degli Infermi, Sc Cardiologia
state: TO
city: Torino
country: Italy
facility: Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia
state: TO
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I - Sc Cardiologia
state: TO
city: Torino
country: Italy
facility: Ospedale Humanitas Gradenigo - Cardiologia
state: TO
city: Torino
country: Italy
facility: Ospedale Giovanni Bosco - Sc Cardiologia
state: TO
city: Alcamo
country: Italy
facility: Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia
state: TP
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia
state: TR
city: Trieste
country: Italy
facility: Asui Trieste - S.C. Centro Cardiovascolare
state: TS
city: Udine
country: Italy
facility: Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
state: UD
city: Saronno
country: Italy
facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
state: VA
city: Mirano
country: Italy
facility: Ospedale Civile - U.O. Cardiologia
state: VE
city: Arzignano
country: Italy
facility: Ospedale Civile - U.O.C. Cardiologia
state: VI
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore - U.O. Di Cardiologia
state: VR
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Miulli - U.O.C. Cardiologia - Utic
city: Borgomanero
country: Italy
facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia
city: Caserta
country: Italy
facility: Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza
city: Chieti
country: Italy
facility: Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna - U.O. Cardiologia - Utic
city: Giugliano In Campania
country: Italy
facility: Ospedale Generale Di Zona - U.O. Cardiologia - Utic
city: Napoli
country: Italy
facility: Fondazione Pascale - S.C. Cardiologia
city: Napoli
country: Italy
facility: Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.
city: Novara
country: Italy
facility: Aou Maggiore Della Carita' - Cardiologia Ii
city: Pescia
country: Italy
facility: Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
city: Roma
country: Italy
facility: Ospedale Sandro Pertini, Uoc Cardiologia
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis - Afdeling Cardioresearch
city: Blaricum
country: Netherlands
facility: Tergooi - Poli cardiologie / poli 2
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - Research Cardiologie
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis - Research Cardiologie
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis - Dept. Cardio Research Noord BV
city: Utrecht
country: Netherlands
facility: Diakonessenhuis - Research Cardiologie
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht - Cardiologie
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum - Poli Cardiologie
city: Amadora
country: Portugal
facility: Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia
city: Barreiro
country: Portugal
facility: Hospital Nossa Senhora do Rosário, Cardiology
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Hospital de Santa Cruz, Cardiology
city: Lisboa
country: Portugal
facility: Hospital Santa Maria, Cardiology
city: Barcelona
country: Spain
facility: Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria
city: Jaén
country: Spain
facility: Hospital Médico-Quirúrgico, Cardiology
city: Madrid
country: Spain
facility: Clínica Anderson, Oncología Médica
city: Madrid
country: Spain
facility: Clínica Medicentro, Cardiología
city: Madrid
country: Spain
facility: Hopsital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital La Moraleja, Servicio de Cardiología
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Zarzuela
city: Madrid
country: Spain
facility: Hospital Montepríncipe, Cardiología
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Rúber Internacional, Oncología
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón, Servicio de Cardiología
city: Murcia
country: Spain
facility: Hospital Virgen de Arrixaca - Cardiologia
city: Salamanca
country: Spain
facility: Hospital de Salamanca, Cardiología
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena, Cardiologia
city: Torrejón De Ardoz
country: Spain
facility: Hospital de Torrejón
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega, Cardiología
city: Valladolid
country: Spain
facility: University Clinical Hosp. de Valladolid, Cardiología
city: Zaragoza
country: Spain
facility: Hospital Clínico "Lozano Blesa", Cardiologia
Study officials:
affiliation: Heart Care Foundation
name: Michele M Gulizia, MD
role: STUDY_CHAIR
References: