Non-interventional Study on Patients With Atrial Fibrillation and Cancer
- Conditions
- CancerAtrial Fibrillation
- Registration Number
- NCT03909386
- Lead Sponsor
- Heart Care Foundation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1514
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy 12 Months Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy
- Secondary Outcome Measures
Name Time Method Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks
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) Baseline and 12 months Number of 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)
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death
Treatment satisfaction Baseline and 12 months Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)
Quality of life satisfaction Baseline and 12 months Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire
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 Baseline and 12 months Number of 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
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding
Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes Baseline and 12 months Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes;
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy Baseline and 12 months Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy
Trial Locations
- Locations (147)
Arcispedale Sant'Anna - U.O. Cardiologia - Utic
🇮🇹Ferrara, Italy
Ospedale Generale Di Zona - U.O. Cardiologia - Utic
🇮🇹Giugliano In Campania, Italy
OLV ZIEKENHUIS AALST - Cardiology
🇧🇪Aalst, Belgium
AZ ST-JAN - Cardiology
🇧🇪Brugge, Belgium
AZ IMELDA - Cardiology
🇧🇪Bonheiden, Belgium
Hôpital Erasme - Cardiology
🇧🇪Brussels, Belgium
UCL Cliniques universitaires Saint-Luc - Cardiolgy
🇧🇪Brussels, Belgium
JESSA HASSELT - Cardiology
🇧🇪Hasselt, Belgium
UZ Brussel - Cardiology
🇧🇪Brussel, Belgium
Ziekenhuis Oost-Limburg - Cardiology
🇧🇪Genk, Belgium
AZ GROENINGE - Cardiology
🇧🇪Kortrijk, Belgium
UZ LEUVEN - Cardiovascular diseases
🇧🇪Leuven, Belgium
AZ TURNHOUT - Cardiology
🇧🇪Turnhout, Belgium
AZ DELTA ROESELARE - Cardiology
🇧🇪Roeselare, Belgium
Beacon Hospital, Cardiology
🇮🇪Dublin, Ireland
Tallaght University Hospital - Geriatric and Stroke Medicine Department
🇮🇪Dublin, Ireland
Ospedale Barone Lombardo - Cardiologia E Utic
🇮🇹Canicattì, AG, Italy
Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic
🇮🇹Agrigento, AG, Italy
Ospedale Civile Profili - U.O. Cardiologia
🇮🇹Fabriano, AN, Italy
Ospedale San Donato - U.O. Cardiologia
🇮🇹Arezzo, AR, Italy
Ospedale San Paolo - Cardiologia-Utic
🇮🇹Bari, BA, Italy
Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia
🇮🇹Bari, BA, Italy
Ospedali Treviglio-Caravaggio - Cardiologia
🇮🇹Treviglio, BG, Italy
Ospedale Maggiore - U.O. Di Cardiologia
🇮🇹Bologna, BO, Italy
Ospedale Civile - Sc Cardiologia
🇮🇹Belluno, BL, Italy
Ospedale Santa Maria Del Prato - U.O. Di Cardiologia
🇮🇹Feltre, BL, Italy
Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi
🇮🇹Bologna, BO, Italy
Ospedale Bellaria - U.O. Di Cardiologia
🇮🇹Bologna, BO, Italy
Ospedale A. Businco - Servizio Di Cardiologia
🇮🇹Cagliari, CA, Italy
Ospedale Roberto Binaghi - Servizio Di Cardiologia
🇮🇹Cagliari, CA, Italy
Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
🇮🇹Santa Maria Capua Vetere, CE, Italy
Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic
🇮🇹Caserta, CE, Italy
Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic
🇮🇹Mondovì, CN, Italy
Ospedale Maggiore Ss. Annunziata - Sc Cardiologia
🇮🇹Savigliano, CN, Italy
Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic
🇮🇹Castrovillari, CS, Italy
Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia
🇮🇹Paola, CS, Italy
P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
🇮🇹Catania, CT, Italy
Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica
🇮🇹Catania, CT, Italy
Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia
🇮🇹Catania, CT, Italy
Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
🇮🇹Foggia, FG, Italy
Ospedale Civile San Giuseppe - Cardiologia
🇮🇹Empoli, FI, Italy
Ospedale San Giovanni Di Dio - Cardiologia
🇮🇹Firenze, FI, Italy
Aou Careggi - Cardiologa Diagnostica
🇮🇹Firenze, FI, Italy
Aou Careggi - Diagnostica Cardiovascolare
🇮🇹Firenze, FI, Italy
Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari
🇮🇹Genova, GE, Italy
Ospedale Padre Antero Micone - Sc Cardiologia - Utic
🇮🇹Genova, GE, Italy
Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
🇮🇹Copertino, LE, Italy
Nuovo Ospedale Versilia - Sc Cardiologia
🇮🇹Lido Di Camaiore, LU, Italy
Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
🇮🇹Scorrano, LE, Italy
Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia
🇮🇹Milano, MI, Italy
Policlinico G. Martino - U.O. Medicina Interna
🇮🇹Messina, ME, Italy
Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc
🇮🇹Vizzolo Predabissi, MI, Italy
Ospedale Ramazzini - U.O. Cardiologia
🇮🇹Carpi, MO, Italy
Istituto Europeo Di Oncologia - Cardiologia
🇮🇹Milano, MI, Italy
Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa
🇮🇹Milano, MI, Italy
Ospedale Di Sassuolo - Cardiologia
🇮🇹Sassuolo, MO, Italy
Ospedale San Francesco - Cardiologia - Utic
🇮🇹Nuoro, NU, Italy
Fondazione G. Giglio - U.O. Cardiologia E Utic
🇮🇹Cefalù, PA, Italy
Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello
🇮🇹Palermo, PA, Italy
Istituto Oncologico Veneto - Cardiologia Oncologica
🇮🇹Padova, PD, Italy
Centro Di Riferimento Oncologico (Cro) - Cardiologia
🇮🇹Aviano, PN, Italy
Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica
🇮🇹Pescara, PE, Italy
Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello
🇮🇹Pisa, PI, Italy
Presidio Ospedaliero San Salvatore - Cardiologia E Utic
🇮🇹Pesaro, PU, Italy
Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica
🇮🇹Pavia, PV, Italy
Fondazione Irccs Policlinico San Matteo - Cardiologia
🇮🇹Pavia, PV, Italy
Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia
🇮🇹Reggio Calabria, RC, Italy
Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia
🇮🇹Ravenna, RA, Italy
Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic
🇮🇹Polistena, RC, Italy
Ospedale Civile - Sc Cardiologia Area Nord
🇮🇹Guastalla, RE, Italy
Arcispedale Santa Maria Nuova - S.C. Cardiologia
🇮🇹Reggio Emilia, RE, Italy
Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic
🇮🇹Ragusa, RG, Italy
Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic
🇮🇹Ariccia, RM, Italy
Campus Biomedico - Cardiologia
🇮🇹Roma, RM, Italy
P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
🇮🇹Roma, RM, Italy
Ospedale San Camillo - Uosd Servizi Cardiologici Integrati
🇮🇹Roma, RM, Italy
Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.
🇮🇹Roma, RM, Italy
Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic
🇮🇹Poggibonsi, SI, Italy
Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
🇮🇹Augusta, SR, Italy
Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa
🇮🇹Sarzana, SP, Italy
Ospedale Di Castellaneta - S.C. Cardiologia
🇮🇹Castellaneta, TA, Italy
Ospedale Civile M. Giannuzzi - Cardiologia E Utic
🇮🇹Manduria, TA, Italy
Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia
🇮🇹Martina Franca, TA, Italy
Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica
🇮🇹Teramo, TE, Italy
Ospedale Santa Maria Del Carmine - Cardiologia
🇮🇹Rovereto, TN, Italy
Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
🇮🇹Orbassano, TO, Italy
Ospedale Civile E. Agnelli - Sc Di Cardiologia
🇮🇹Pinerolo, TO, Italy
Ospedale Degli Infermi, Sc Cardiologia
🇮🇹Rivoli, TO, Italy
Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia
🇮🇹Torino, TO, Italy
Ospedale Mauriziano Umberto I - Sc Cardiologia
🇮🇹Torino, TO, Italy
Ospedale Humanitas Gradenigo - Cardiologia
🇮🇹Torino, TO, Italy
Ospedale Giovanni Bosco - Sc Cardiologia
🇮🇹Torino, TO, Italy
Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia
🇮🇹Alcamo, TP, Italy
Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia
🇮🇹Terni, TR, Italy
Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
🇮🇹Udine, UD, Italy
Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
🇮🇹Saronno, VA, Italy
Ospedale Civile - U.O.C. Cardiologia
🇮🇹Arzignano, VI, Italy
Ospedale Civile - U.O. Cardiologia
🇮🇹Mirano, VE, Italy
Ospedale Sacro Cuore - U.O. Di Cardiologia
🇮🇹Negrar, VR, Italy
Ospedale Miulli - U.O.C. Cardiologia - Utic
🇮🇹Acquaviva Delle Fonti, Italy
Ospedale Ss. Trinita' - S.C. Di Cardiologia
🇮🇹Borgomanero, Italy
Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii
🇮🇹Chieti, Italy
Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza
🇮🇹Caserta, Italy
Fondazione Pascale - S.C. Cardiologia
🇮🇹Napoli, Italy
Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.
🇮🇹Napoli, Italy
Aou Maggiore Della Carita' - Cardiologia Ii
🇮🇹Novara, Italy
Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic
🇮🇹Pescia, Italy
Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
🇮🇹Pozzuoli, Italy
Ospedale Sandro Pertini, Uoc Cardiologia
🇮🇹Roma, Italy
Tergooi - Poli cardiologie / poli 2
🇳🇱Blaricum, Netherlands
Rijnstate Ziekenhuis - Afdeling Cardioresearch
🇳🇱Arnhem, Netherlands
Amphia Ziekenhuis - Research Cardiologie
🇳🇱Breda, Netherlands
Martini Ziekenhuis - Dept. Cardio Research Noord BV
🇳🇱Groningen, Netherlands
Diakonessenhuis - Research Cardiologie
🇳🇱Utrecht, Netherlands
Máxima Medisch Centrum - Poli Cardiologie
🇳🇱Veldhoven, Netherlands
Hospital Nossa Senhora do Rosário, Cardiology
🇵🇹Barreiro, Portugal
Hospital da Luz
🇵🇹Lisboa, Portugal
Hospital de Santa Cruz, Cardiology
🇵🇹Lisboa, Portugal
Hospital Santa Maria, Cardiology
🇵🇹Lisboa, Portugal
Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria
🇪🇸Barcelona, Spain
Clínica Anderson, Oncología Médica
🇪🇸Madrid, Spain
Hospital Médico-Quirúrgico, Cardiology
🇪🇸Jaén, Spain
Clínica Medicentro, Cardiología
🇪🇸Madrid, Spain
Hospital La Moraleja, Servicio de Cardiología
🇪🇸Madrid, Spain
Hospital La Zarzuela
🇪🇸Madrid, Spain
Hopsital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Rúber Internacional, Oncología
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañón, Servicio de Cardiología
🇪🇸Madrid, Spain
Hospital Virgen de Arrixaca - Cardiologia
🇪🇸Murcia, Spain
Hospital de Salamanca, Cardiología
🇪🇸Salamanca, Spain
Hospital de Torrejón
🇪🇸Torrejón De Ardoz, Spain
Hospital Universitario Virgen Macarena, Cardiologia
🇪🇸Sevilla, Spain
Hospital Universitario Río Hortega, Cardiología
🇪🇸Valladolid, Spain
University Clinical Hosp. de Valladolid, Cardiología
🇪🇸Valladolid, Spain
Hospital Clínico "Lozano Blesa", Cardiologia
🇪🇸Zaragoza, Spain
Jeroen Bosch Ziekenhuis - Research Cardiologie
🇳🇱Den Bosch, Netherlands
University Medical Center Utrecht - Cardiologie
🇳🇱Utrecht, Netherlands
Ospedale Santo Spirito - Sc Cardiologia
🇮🇹Casale Monferrato, AL, Italy
Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia
🇮🇹Roma, RM, Italy
Ospedale G. Ceccarini - Cardiologia-Utic
🇮🇹Riccione, RN, Italy
Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva
🇮🇹Salerno, SA, Italy
Asui Trieste - S.C. Centro Cardiovascolare
🇮🇹Trieste, TS, Italy
Bon Secours Hospital Cork - Oncology Department
🇮🇪Cork, Ireland
Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia
🇵🇹Amadora, Portugal
Hospital Montepríncipe, Cardiología
🇪🇸Madrid, Spain