NCT03909386

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
6 countries

147 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

April 5, 2019

Last Update Submit

January 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Baseline

  • Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    12 Months

Secondary Outcomes (19)

  • Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke

    Baseline and 12 months

  • Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks

    Baseline and 12 months

  • 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

  • Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events

    Baseline and 12 months

  • Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome

    Baseline and 12 months

  • +14 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (147)

OLV ZIEKENHUIS AALST - Cardiology

Aalst, Belgium

Location

AZ IMELDA - Cardiology

Bonheiden, Belgium

Location

AZ ST-JAN - Cardiology

Bruges, Belgium

Location

Hôpital Erasme - Cardiology

Brussels, Belgium

Location

UCL Cliniques universitaires Saint-Luc - Cardiolgy

Brussels, Belgium

Location

UZ Brussel - Cardiology

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg - Cardiology

Genk, Belgium

Location

JESSA HASSELT - Cardiology

Hasselt, Belgium

Location

AZ GROENINGE - Cardiology

Kortrijk, Belgium

Location

UZ LEUVEN - Cardiovascular diseases

Leuven, Belgium

Location

AZ DELTA ROESELARE - Cardiology

Roeselare, Belgium

Location

AZ TURNHOUT - Cardiology

Turnhout, Belgium

Location

Bon Secours Hospital Cork - Oncology Department

Cork, Ireland

Location

Beacon Hospital, Cardiology

Dublin, Ireland

Location

Tallaght University Hospital - Geriatric and Stroke Medicine Department

Dublin, Ireland

Location

Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic

Agrigento, AG, 92100, Italy

Location

Ospedale Barone Lombardo - Cardiologia E Utic

Canicattì, AG, 92024, Italy

Location

Ospedale Santo Spirito - Sc Cardiologia

Casale Monferrato, AL, 15033, Italy

Location

Ospedale Civile Profili - U.O. Cardiologia

Fabriano, AN, 60044, Italy

Location

Ospedale San Donato - U.O. Cardiologia

Arezzo, AR, 52100, Italy

Location

Ospedale San Paolo - Cardiologia-Utic

Bari, BA, 70123, Italy

Location

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

Bari, BA, 70124, Italy

Location

Ospedali Treviglio-Caravaggio - Cardiologia

Treviglio, BG, 24047, Italy

Location

Ospedale Civile - Sc Cardiologia

Belluno, BL, 32100, Italy

Location

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

Feltre, BL, 32032, Italy

Location

Ospedale Maggiore - U.O. Di Cardiologia

Bologna, BO, 40133, Italy

Location

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

Bologna, BO, 40138, Italy

Location

Ospedale Bellaria - U.O. Di Cardiologia

Bologna, BO, 40139, Italy

Location

Ospedale A. Businco - Servizio Di Cardiologia

Cagliari, CA, 09121, Italy

Location

Ospedale Roberto Binaghi - Servizio Di Cardiologia

Cagliari, CA, 09126, Italy

Location

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

Caserta, CE, 81100, Italy

Location

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

Santa Maria Capua Vetere, CE, 81055, Italy

Location

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

Mondovì, CN, 12084, Italy

Location

Ospedale Maggiore Ss. Annunziata - Sc Cardiologia

Savigliano, CN, 12038, Italy

Location

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

Castrovillari, CS, 87012, Italy

Location

Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia

Paola, CS, 87027, Italy

Location

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

Catania, CT, 95122, Italy

Location

Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica

Catania, CT, 95126, Italy

Location

Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia

Catania, CT, 95126, Italy

Location

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

Foggia, FG, 71100, Italy

Location

Ospedale Civile San Giuseppe - Cardiologia

Empoli, FI, 50053, Italy

Location

Ospedale San Giovanni Di Dio - Cardiologia

Florence, FI, 50124, Italy

Location

Aou Careggi - Cardiologa Diagnostica

Florence, FI, 50134, Italy

Location

Aou Careggi - Diagnostica Cardiovascolare

Florence, FI, 50139, Italy

Location

Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari

Genova, GE, 16132, Italy

Location

Ospedale Padre Antero Micone - Sc Cardiologia - Utic

Genova, GE, 16153, Italy

Location

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

Copertino, LE, 73043, Italy

Location

Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

Scorrano, LE, 73020, Italy

Location

Nuovo Ospedale Versilia - Sc Cardiologia

Lido di Camaiore, LU, 55043, Italy

Location

Policlinico G. Martino - U.O. Medicina Interna

Messina, ME, 98124, Italy

Location

Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia

Milan, MI, 20133, Italy

Location

Istituto Europeo Di Oncologia - Cardiologia

Milan, MI, 20141, Italy

Location

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

Milan, MI, 20162, Italy

Location

Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc

Vizzolo Predabissi, MI, 20077, Italy

Location

Ospedale Ramazzini - U.O. Cardiologia

Carpi, MO, 41013, Italy

Location

Ospedale Di Sassuolo - Cardiologia

Sassuolo, MO, 41049, Italy

Location

Ospedale San Francesco - Cardiologia - Utic

Nuoro, NU, 08100, Italy

Location

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

Cefalù, PA, 90015, Italy

Location

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

Palermo, PA, 90146, Italy

Location

Istituto Oncologico Veneto - Cardiologia Oncologica

Padua, PD, 35128, Italy

Location

Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica

Pescara, PE, 65124, Italy

Location

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

Pisa, PI, 26124, Italy

Location

Centro Di Riferimento Oncologico (Cro) - Cardiologia

Aviano, PN, 33081, Italy

Location

Presidio Ospedaliero San Salvatore - Cardiologia E Utic

Pesaro, PU, 61121, Italy

Location

Fondazione Irccs Policlinico San Matteo - Cardiologia

Pavia, PV, 27100, Italy

Location

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

Pavia, PV, 27100, Italy

Location

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

Ravenna, RA, 48100, Italy

Location

Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic

Polistena, RC, 89024, Italy

Location

Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia

Reggio Calabria, RC, 89124, Italy

Location

Ospedale Civile - Sc Cardiologia Area Nord

Guastalla, RE, 42016, Italy

Location

Arcispedale Santa Maria Nuova - S.C. Cardiologia

Reggio Emilia, RE, 42100, Italy

Location

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

Ragusa, RG, 97100, Italy

Location

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

Ariccia, RM, 00072, Italy

Location

Campus Biomedico - Cardiologia

Roma, RM, 00128, Italy

Location

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

Roma, RM, 00135, Italy

Location

Ospedale San Camillo - Uosd Servizi Cardiologici Integrati

Roma, RM, 00151, Italy

Location

Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia

Roma, RM, 00152, Italy

Location

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

Roma, RM, 00168, Italy

Location

Ospedale G. Ceccarini - Cardiologia-Utic

Riccione, RN, 47838, Italy

Location

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

Salerno, SA, 84131, Italy

Location

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

Poggibonsi, SI, 53036, Italy

Location

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

Sarzana, SP, 19038, Italy

Location

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

Augusta, SR, 96011, Italy

Location

Ospedale Di Castellaneta - S.C. Cardiologia

Castellaneta, TA, 74011, Italy

Location

Ospedale Civile M. Giannuzzi - Cardiologia E Utic

Manduria, TA, 74024, Italy

Location

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

Martina Franca, TA, 74015, Italy

Location

Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica

Teramo, TE, 64100, Italy

Location

Ospedale Santa Maria Del Carmine - Cardiologia

Rovereto, TN, 38068, Italy

Location

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

Orbassano, TO, 10043, Italy

Location

Ospedale Civile E. Agnelli - Sc Di Cardiologia

Pinerolo, TO, 10064, Italy

Location

Ospedale Degli Infermi, Sc Cardiologia

Rivoli, TO, Italy

Location

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

Torino, TO, 10126, Italy

Location

Ospedale Mauriziano Umberto I - Sc Cardiologia

Torino, TO, 10128, Italy

Location

Ospedale Humanitas Gradenigo - Cardiologia

Torino, TO, 10153, Italy

Location

Ospedale Giovanni Bosco - Sc Cardiologia

Torino, TO, 10155, Italy

Location

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

Alcamo, TP, 91011, Italy

Location

Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia

Terni, TR, 05100, Italy

Location

Asui Trieste - S.C. Centro Cardiovascolare

Trieste, TS, 34125, Italy

Location

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

Udine, UD, 33100, Italy

Location

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

Saronno, VA, 21047, Italy

Location

Ospedale Civile - U.O. Cardiologia

Mirano, VE, 30035, Italy

Location

Ospedale Civile - U.O.C. Cardiologia

Arzignano, VI, 36071, Italy

Location

Ospedale Sacro Cuore - U.O. Di Cardiologia

Negrar, VR, 37024, Italy

Location

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

Acquaviva delle Fonti, Italy

Location

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

Borgomanero, 28021, Italy

Location

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

Caserta, Italy

Location

Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii

Chieti, Italy

Location

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

Ferrara, Italy

Location

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

Giugliano in Campania, 80014, Italy

Location

Fondazione Pascale - S.C. Cardiologia

Napoli, 80131, Italy

Location

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

Napoli, 80136, Italy

Location

Aou Maggiore Della Carita' - Cardiologia Ii

Novara, 28100, Italy

Location

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

Pescia, Italy

Location

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

Pozzuoli, 80078, Italy

Location

Ospedale Sandro Pertini, Uoc Cardiologia

Roma, Italy

Location

Jeroen Bosch Ziekenhuis - Research Cardiologie

's-Hertogenbosch, Netherlands

Location

Rijnstate Ziekenhuis - Afdeling Cardioresearch

Arnhem, Netherlands

Location

Tergooi - Poli cardiologie / poli 2

Blaricum, Netherlands

Location

Amphia Ziekenhuis - Research Cardiologie

Breda, Netherlands

Location

Martini Ziekenhuis - Dept. Cardio Research Noord BV

Groningen, Netherlands

Location

Diakonessenhuis - Research Cardiologie

Utrecht, Netherlands

Location

University Medical Center Utrecht - Cardiologie

Utrecht, Netherlands

Location

Máxima Medisch Centrum - Poli Cardiologie

Veldhoven, Netherlands

Location

Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia

Amadora, Portugal

Location

Hospital Nossa Senhora do Rosário, Cardiology

Barreiro, Portugal

Location

Hospital da Luz

Lisbon, Portugal

Location

Hospital de Santa Cruz, Cardiology

Lisbon, Portugal

Location

Hospital Santa Maria, Cardiology

Lisbon, Portugal

Location

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

Barcelona, Spain

Location

Hospital Médico-Quirúrgico, Cardiology

Jaén, Spain

Location

Clínica Anderson, Oncología Médica

Madrid, Spain

Location

Clínica Medicentro, Cardiología

Madrid, Spain

Location

Hopsital Puerta de Hierro

Madrid, Spain

Location

Hospital La Moraleja, Servicio de Cardiología

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Hospital La Zarzuela

Madrid, Spain

Location

Hospital Montepríncipe, Cardiología

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Rúber Internacional, Oncología

Madrid, Spain

Location

Hospital Universitario Gregorio Marañón, Servicio de Cardiología

Madrid, Spain

Location

Hospital Virgen de Arrixaca - Cardiologia

Murcia, Spain

Location

Hospital de Salamanca, Cardiología

Salamanca, Spain

Location

Hospital Universitario Virgen Macarena, Cardiologia

Seville, Spain

Location

Hospital de Torrejón

Torrejón de Ardoz, Spain

Location

Hospital Universitario Río Hortega, Cardiología

Valladolid, Spain

Location

University Clinical Hosp. de Valladolid, Cardiología

Valladolid, Spain

Location

Hospital Clínico "Lozano Blesa", Cardiologia

Zaragoza, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Atrial FibrillationNeoplasms

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michele M Gulizia, MD

    Heart Care Foundation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 10, 2019

Study Start

June 26, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations