Non-interventional Study on Patients With Atrial Fibrillation and Cancer

NCT ID: NCT03909386

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1514 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Care Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele M Gulizia, MD

Role: STUDY_CHAIR

Heart Care Foundation

Locations

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OLV ZIEKENHUIS AALST - Cardiology

Aalst, , Belgium

Site Status

AZ IMELDA - Cardiology

Bonheiden, , Belgium

Site Status

AZ ST-JAN - Cardiology

Bruges, , Belgium

Site Status

Hôpital Erasme - Cardiology

Brussels, , Belgium

Site Status

UCL Cliniques universitaires Saint-Luc - Cardiolgy

Brussels, , Belgium

Site Status

UZ Brussel - Cardiology

Brussels, , Belgium

Site Status

Ziekenhuis Oost-Limburg - Cardiology

Genk, , Belgium

Site Status

JESSA HASSELT - Cardiology

Hasselt, , Belgium

Site Status

AZ GROENINGE - Cardiology

Kortrijk, , Belgium

Site Status

UZ LEUVEN - Cardiovascular diseases

Leuven, , Belgium

Site Status

AZ DELTA ROESELARE - Cardiology

Roeselare, , Belgium

Site Status

AZ TURNHOUT - Cardiology

Turnhout, , Belgium

Site Status

Bon Secours Hospital Cork - Oncology Department

Cork, , Ireland

Site Status

Beacon Hospital, Cardiology

Dublin, , Ireland

Site Status

Tallaght University Hospital - Geriatric and Stroke Medicine Department

Dublin, , Ireland

Site Status

Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic

Agrigento, AG, Italy

Site Status

Ospedale Barone Lombardo - Cardiologia E Utic

Canicattì, AG, Italy

Site Status

Ospedale Santo Spirito - Sc Cardiologia

Casale Monferrato, AL, Italy

Site Status

Ospedale Civile Profili - U.O. Cardiologia

Fabriano, AN, Italy

Site Status

Ospedale San Donato - U.O. Cardiologia

Arezzo, AR, Italy

Site Status

Ospedale San Paolo - Cardiologia-Utic

Bari, BA, Italy

Site Status

Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia

Bari, BA, Italy

Site Status

Ospedali Treviglio-Caravaggio - Cardiologia

Treviglio, BG, Italy

Site Status

Ospedale Civile - Sc Cardiologia

Belluno, BL, Italy

Site Status

Ospedale Santa Maria Del Prato - U.O. Di Cardiologia

Feltre, BL, Italy

Site Status

Ospedale Maggiore - U.O. Di Cardiologia

Bologna, BO, Italy

Site Status

Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi

Bologna, BO, Italy

Site Status

Ospedale Bellaria - U.O. Di Cardiologia

Bologna, BO, Italy

Site Status

Ospedale A. Businco - Servizio Di Cardiologia

Cagliari, CA, Italy

Site Status

Ospedale Roberto Binaghi - Servizio Di Cardiologia

Cagliari, CA, Italy

Site Status

Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic

Caserta, CE, Italy

Site Status

Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic

Santa Maria Capua Vetere, CE, Italy

Site Status

Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic

Mondovì, CN, Italy

Site Status

Ospedale Maggiore Ss. Annunziata - Sc Cardiologia

Savigliano, CN, Italy

Site Status

Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic

Castrovillari, CS, Italy

Site Status

Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia

Paola, CS, Italy

Site Status

P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia

Catania, CT, Italy

Site Status

Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica

Catania, CT, Italy

Site Status

Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia

Catania, CT, Italy

Site Status

Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic

Foggia, FG, Italy

Site Status

Ospedale Civile San Giuseppe - Cardiologia

Empoli, FI, Italy

Site Status

Ospedale San Giovanni Di Dio - Cardiologia

Florence, FI, Italy

Site Status

Aou Careggi - Cardiologa Diagnostica

Florence, FI, Italy

Site Status

Aou Careggi - Diagnostica Cardiovascolare

Florence, FI, Italy

Site Status

Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari

Genova, GE, Italy

Site Status

Ospedale Padre Antero Micone - Sc Cardiologia - Utic

Genova, GE, Italy

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Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic

Copertino, LE, Italy

Site Status

Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

Scorrano, LE, Italy

Site Status

Nuovo Ospedale Versilia - Sc Cardiologia

Lido di Camaiore, LU, Italy

Site Status

Policlinico G. Martino - U.O. Medicina Interna

Messina, ME, Italy

Site Status

Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia

Milan, MI, Italy

Site Status

Istituto Europeo Di Oncologia - Cardiologia

Milan, MI, Italy

Site Status

Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa

Milan, MI, Italy

Site Status

Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc

Vizzolo Predabissi, MI, Italy

Site Status

Ospedale Ramazzini - U.O. Cardiologia

Carpi, MO, Italy

Site Status

Ospedale Di Sassuolo - Cardiologia

Sassuolo, MO, Italy

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Ospedale San Francesco - Cardiologia - Utic

Nuoro, NU, Italy

Site Status

Fondazione G. Giglio - U.O. Cardiologia E Utic

Cefalù, PA, Italy

Site Status

Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello

Palermo, PA, Italy

Site Status

Istituto Oncologico Veneto - Cardiologia Oncologica

Padua, PD, Italy

Site Status

Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica

Pescara, PE, Italy

Site Status

Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello

Pisa, PI, Italy

Site Status

Centro Di Riferimento Oncologico (Cro) - Cardiologia

Aviano, PN, Italy

Site Status

Presidio Ospedaliero San Salvatore - Cardiologia E Utic

Pesaro, PU, Italy

Site Status

Fondazione Irccs Policlinico San Matteo - Cardiologia

Pavia, PV, Italy

Site Status

Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica

Pavia, PV, Italy

Site Status

Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia

Ravenna, RA, Italy

Site Status

Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic

Polistena, RC, Italy

Site Status

Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia

Reggio Calabria, RC, Italy

Site Status

Ospedale Civile - Sc Cardiologia Area Nord

Guastalla, RE, Italy

Site Status

Arcispedale Santa Maria Nuova - S.C. Cardiologia

Reggio Emilia, RE, Italy

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Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic

Ragusa, RG, Italy

Site Status

Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic

Ariccia, RM, Italy

Site Status

Campus Biomedico - Cardiologia

Roma, RM, Italy

Site Status

P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic

Roma, RM, Italy

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Ospedale San Camillo - Uosd Servizi Cardiologici Integrati

Roma, RM, Italy

Site Status

Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia

Roma, RM, Italy

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Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.

Roma, RM, Italy

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Ospedale G. Ceccarini - Cardiologia-Utic

Riccione, RN, Italy

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Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva

Salerno, SA, Italy

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Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic

Poggibonsi, SI, Italy

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Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa

Sarzana, SP, Italy

Site Status

Ospedale E. Muscatello - U.O. Di Cardiologia - Utic

Augusta, SR, Italy

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Ospedale Di Castellaneta - S.C. Cardiologia

Castellaneta, TA, Italy

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Ospedale Civile M. Giannuzzi - Cardiologia E Utic

Manduria, TA, Italy

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Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia

Martina Franca, TA, Italy

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Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica

Teramo, TE, Italy

Site Status

Ospedale Santa Maria Del Carmine - Cardiologia

Rovereto, TN, Italy

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Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia

Orbassano, TO, Italy

Site Status

Ospedale Civile E. Agnelli - Sc Di Cardiologia

Pinerolo, TO, Italy

Site Status

Ospedale Degli Infermi, Sc Cardiologia

Rivoli, TO, Italy

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Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia

Torino, TO, Italy

Site Status

Ospedale Mauriziano Umberto I - Sc Cardiologia

Torino, TO, Italy

Site Status

Ospedale Humanitas Gradenigo - Cardiologia

Torino, TO, Italy

Site Status

Ospedale Giovanni Bosco - Sc Cardiologia

Torino, TO, Italy

Site Status

Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia

Alcamo, TP, Italy

Site Status

Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia

Terni, TR, Italy

Site Status

Asui Trieste - S.C. Centro Cardiovascolare

Trieste, TS, Italy

Site Status

Pou Santa Maria Della Misericordia - S.O.C. Cardiologia

Udine, UD, Italy

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Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia

Saronno, VA, Italy

Site Status

Ospedale Civile - U.O. Cardiologia

Mirano, VE, Italy

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Ospedale Civile - U.O.C. Cardiologia

Arzignano, VI, Italy

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Ospedale Sacro Cuore - U.O. Di Cardiologia

Negrar, VR, Italy

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Ospedale Miulli - U.O.C. Cardiologia - Utic

Acquaviva delle Fonti, , Italy

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Ospedale Ss. Trinita' - S.C. Di Cardiologia

Borgomanero, , Italy

Site Status

Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza

Caserta, , Italy

Site Status

Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii

Chieti, , Italy

Site Status

Arcispedale Sant'Anna - U.O. Cardiologia - Utic

Ferrara, , Italy

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Ospedale Generale Di Zona - U.O. Cardiologia - Utic

Giugliano in Campania, , Italy

Site Status

Fondazione Pascale - S.C. Cardiologia

Napoli, , Italy

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Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.

Napoli, , Italy

Site Status

Aou Maggiore Della Carita' - Cardiologia Ii

Novara, , Italy

Site Status

Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic

Pescia, , Italy

Site Status

Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic

Pozzuoli, , Italy

Site Status

Ospedale Sandro Pertini, Uoc Cardiologia

Roma, , Italy

Site Status

Jeroen Bosch Ziekenhuis - Research Cardiologie

's-Hertogenbosch, , Netherlands

Site Status

Rijnstate Ziekenhuis - Afdeling Cardioresearch

Arnhem, , Netherlands

Site Status

Tergooi - Poli cardiologie / poli 2

Blaricum, , Netherlands

Site Status

Amphia Ziekenhuis - Research Cardiologie

Breda, , Netherlands

Site Status

Martini Ziekenhuis - Dept. Cardio Research Noord BV

Groningen, , Netherlands

Site Status

Diakonessenhuis - Research Cardiologie

Utrecht, , Netherlands

Site Status

University Medical Center Utrecht - Cardiologie

Utrecht, , Netherlands

Site Status

Máxima Medisch Centrum - Poli Cardiologie

Veldhoven, , Netherlands

Site Status

Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia

Amadora, , Portugal

Site Status

Hospital Nossa Senhora do Rosário, Cardiology

Barreiro, , Portugal

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Hospital da Luz

Lisbon, , Portugal

Site Status

Hospital de Santa Cruz, Cardiology

Lisbon, , Portugal

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Hospital Santa Maria, Cardiology

Lisbon, , Portugal

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Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria

Barcelona, , Spain

Site Status

Hospital Médico-Quirúrgico, Cardiology

Jaén, , Spain

Site Status

Clínica Anderson, Oncología Médica

Madrid, , Spain

Site Status

Clínica Medicentro, Cardiología

Madrid, , Spain

Site Status

Hopsital Puerta de Hierro

Madrid, , Spain

Site Status

Hospital La Moraleja, Servicio de Cardiología

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

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Hospital La Zarzuela

Madrid, , Spain

Site Status

Hospital Montepríncipe, Cardiología

Madrid, , Spain

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Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Rúber Internacional, Oncología

Madrid, , Spain

Site Status

Hospital Universitario Gregorio Marañón, Servicio de Cardiología

Madrid, , Spain

Site Status

Hospital Virgen de Arrixaca - Cardiologia

Murcia, , Spain

Site Status

Hospital de Salamanca, Cardiología

Salamanca, , Spain

Site Status

Hospital Universitario Virgen Macarena, Cardiologia

Seville, , Spain

Site Status

Hospital de Torrejón

Torrejón de Ardoz, , Spain

Site Status

Hospital Universitario Río Hortega, Cardiología

Valladolid, , Spain

Site Status

University Clinical Hosp. de Valladolid, Cardiología

Valladolid, , Spain

Site Status

Hospital Clínico "Lozano Blesa", Cardiologia

Zaragoza, , Spain

Site Status

Countries

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Belgium Ireland Italy Netherlands Portugal Spain

References

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Gulizia MM, Turazza FM, Ameri P, Alings M, Collins R, De Luca L, Di Nisio M, Lucci D, Gabrielli D, Janssens S, Parrini I, Pinto FJ, Zamorano J, Colivicchi F; BLITZ-AF Cancer Investigators. Characteristics and Management of Patients With Cancer and Atrial Fibrillation: The BLITZ-AF Cancer Registry. JACC Adv. 2024 May 24;3(7):100991. doi: 10.1016/j.jacadv.2024.100991. eCollection 2024 Jul.

Reference Type DERIVED
PMID: 39130025 (View on PubMed)

Other Identifiers

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K21

Identifier Type: -

Identifier Source: org_study_id

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