BLITZ-AFCancer: Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Sponsor
Heart Care Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03909386
Collaborator
(none)
1,514
Enrollment
119
Locations
48.1
Anticipated Duration (Months)
12.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1514 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)
    Actual Study Start Date :
    Jun 26, 2019
    Anticipated Primary Completion Date :
    Jun 26, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy [Baseline]

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

    2. 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

    1. 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

    2. 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

    3. 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)

    4. 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

    5. 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

    6. 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

    7. 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

    8. 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

    9. 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

    10. 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

    11. 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

    12. 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

    13. 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

    14. 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

    15. 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

    16. Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes [Baseline and 12 months]

      Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes

    17. 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;

    18. Treatment satisfaction [Baseline and 12 months]

      Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)

    19. Quality of life satisfaction [Baseline and 12 months]

      Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1OLV ZIEKENHUIS AALST - CardiologyAalstBelgium
    2AZ IMELDA - CardiologyBonheidenBelgium
    3AZ ST-JAN - CardiologyBruggeBelgium
    4UZ Brussel - CardiologyBrusselBelgium
    5Ziekenhuis Oost-Limburg - CardiologyGenkBelgium
    6JESSA HASSELT - CardiologyHasseltBelgium
    7AZ GROENINGE - CardiologyKortrijkBelgium
    8UZ LEUVEN - Cardiovascular diseasesLeuvenBelgium
    9AZ DELTA ROESELARE - CardiologyRoeselareBelgium
    10Beacon Hospital, CardiologyDublinIreland
    11Tallaght University Hospital - Geriatric and Stroke Medicine DepartmentDublinIreland
    12Ospedale San Giovanni Di Dio - Uo Cardiologia E UticAgrigentoAGItaly92100
    13Ospedale Barone Lombardo - Cardiologia E UticCanicattìAGItaly92024
    14Ospedale Santo Spirito - Sc CardiologiaCasale MonferratoALItaly15033
    15Ospedale Civile Profili - U.O. CardiologiaFabrianoANItaly60044
    16Ospedale San Paolo - Cardiologia-UticBariBAItaly70123
    17Istituto Tumori Giovanni Paolo Ii - U.O. Di CardiologiaBariBAItaly70124
    18Ospedali Treviglio-Caravaggio - CardiologiaTreviglioBGItaly24047
    19Ospedale Civile - Sc CardiologiaBellunoBLItaly32100
    20Ospedale Santa Maria Del Prato - U.O. Di CardiologiaFeltreBLItaly32032
    21Ospedale Maggiore - U.O. Di CardiologiaBolognaBOItaly40133
    22Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-RapezziBolognaBOItaly40138
    23Ospedale Bellaria - U.O. Di CardiologiaBolognaBOItaly40139
    24Ospedale A. Businco - Servizio Di CardiologiaCagliariCAItaly09121
    25Ospedale Roberto Binaghi - Servizio Di CardiologiaCagliariCAItaly09126
    26Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - UticCasertaCEItaly81100
    27Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia UticSanta Maria Capua VetereCEItaly81055
    28Ospedale Regina Montis Regalis - U.O. Cardiologia-UticMondovìCNItaly12084
    29Ospedale Maggiore Ss. Annunziata - Sc CardiologiaSaviglianoCNItaly12038
    30Ospedale Civile Ferrari - U.O.C. Cardiologia-UticCastrovillariCSItaly87012
    31Ospedale Spoke Paola- Cetraro Po Paola - Utic CardiologiaPaolaCSItaly87027
    32P.O. Garibaldi-Nesima - U.O.C. Di CardiologiaCataniaCTItaly95122
    33Ospedali Riuniti - S.C. Di Cardiologia Univ.-UticFoggiaFGItaly71100
    34Ospedale Civile San Giuseppe - CardiologiaEmpoliFIItaly50053
    35Ospedale San Giovanni Di Dio - CardiologiaFirenzeFIItaly50124
    36Aou Careggi - Cardiologa DiagnosticaFirenzeFIItaly50134
    37Aou Careggi - Diagnostica CardiovascolareFirenzeFIItaly50139
    38Ospedale Policlinico San Martino - Clinica Malattie CardiovascolariGenovaGEItaly16132
    39Ospedale Padre Antero Micone - Sc Cardiologia - UticGenovaGEItaly16153
    40Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-UticCopertinoLEItaly73043
    41Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-UticScorranoLEItaly73020
    42Nuovo Ospedale Versilia - Sc CardiologiaLido Di CamaioreLUItaly55043
    43Policlinico G. Martino - U.O. Medicina InternaMessinaMEItaly98124
    44Istituto Nazionale Tumori - Struttura Complessa Di CardiologiaMilanoMIItaly20133
    45Istituto Europeo Di Oncologia - CardiologiaMilanoMIItaly20141
    46Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E RiabilitativaMilanoMIItaly20162
    47Ospedale Di Vizzolo Predabissi - Uo Cardiologia E UccVizzolo PredabissiMIItaly20077
    48Ospedale Di Sassuolo - CardiologiaSassuoloMOItaly41049
    49Ospedale San Francesco - Cardiologia - UticNuoroNUItaly08100
    50Fondazione G. Giglio - U.O. Cardiologia E UticCefalùPAItaly90015
    51Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - CervelloPalermoPAItaly90146
    52Istituto Oncologico Veneto - Cardiologia OncologicaPadovaPDItaly35128
    53Ospedale Civile Dello Spirito Santo - Utic E Cardiologia InterventisticaPescaraPEItaly65124
    54Centro Di Riferimento Oncologico (Cro) - CardiologiaAvianoPNItaly33081
    55Presidio Ospedaliero San Salvatore - Cardiologia E UticPesaroPUItaly61121
    56Fondazione Irccs Policlinico San Matteo - CardiologiaPaviaPVItaly27100
    57Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione CardiologicaPaviaPVItaly27100
    58Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-UticPolistenaRCItaly89024
    59Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di CardiologiaReggio CalabriaRCItaly89124
    60Ospedale Civile - Sc Cardiologia Area NordGuastallaREItaly42016
    61Arcispedale Santa Maria Nuova - S.C. CardiologiaReggio EmiliaREItaly42100
    62Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-UticRagusaRGItaly97100
    63Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E UticAricciaRMItaly00072
    64P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E UticRomaRMItaly00135
    65Ospedale San Camillo - Uosd Servizi Cardiologici IntegratiRomaRMItaly00151
    66Ifo- Istituto Naz. Tumori Regina Elena - Uo CardiologiaRomaRMItaly00152
    67Ospedale G. Ceccarini - Cardiologia-UticRiccioneRNItaly47838
    68Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-UticPoggibonsiSIItaly53036
    69Ospedale San Bartolomeo - U.O. Cardiologia Clinica-RiabilitativaSarzanaSPItaly19038
    70Ospedale Di Castellaneta - S.C. CardiologiaCastellanetaTAItaly74011
    71Ospedale Civile M. Giannuzzi - Cardiologia E UticManduriaTAItaly74024
    72Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di CardiologiaMartina FrancaTAItaly74015
    73Ospedale Civile G. Mazzini - Cardiologia Utic Ed EmodinamicaTeramoTEItaly64100
    74Ospedale Santa Maria Del Carmine - CardiologiaRoveretoTNItaly38068
    75Ospedale San Luigi Gonzaga - S.C.D.O. CardiologiaOrbassanoTOItaly10043
    76Ospedale Degli Infermi, Sc CardiologiaRivoliTOItaly
    77Aou Citta' Della Salute E Della Scienza - S.C.D.U. CardiologiaTorinoTOItaly10126
    78Ospedale Mauriziano Umberto I - Sc CardiologiaTorinoTOItaly10128
    79Ospedale Humanitas Gradenigo - CardiologiaTorinoTOItaly10153
    80Ospedale Giovanni Bosco - Sc CardiologiaTorinoTOItaly10155
    81Azienda Ospedaliera Santa Maria - S.C. Di CardiologiaTerniTRItaly05100
    82Asui Trieste - S.C. Centro CardiovascolareTriesteTSItaly34125
    83Pou Santa Maria Della Misericordia - S.O.C. CardiologiaUdineUDItaly33100
    84Presidio Ospedaliero Di Saronno - U.O.C. Di CardiologiaSaronnoVAItaly21047
    85Ospedale Civile - U.O. CardiologiaMiranoVEItaly30035
    86Ospedale Civile - U.O.C. CardiologiaArzignanoVIItaly36071
    87Ospedale Miulli - U.O.C. Cardiologia - UticAcquaviva Delle FontiItaly
    88Ospedale Ss. Trinita' - S.C. Di CardiologiaBorgomaneroItaly28021
    89Ospedale Policlinico Ss. Annunziata - Medicina Generale IiChietiItaly
    90Arcispedale Sant'Anna - U.O. Cardiologia - UticFerraraItaly
    91Ospedale Generale Di Zona - U.O. Cardiologia - UticGiugliano In CampaniaItaly80014
    92Fondazione Pascale - S.C. CardiologiaNapoliItaly80131
    93Aou Maggiore Della Carita' - Cardiologia IiNovaraItaly28100
    94Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - UticPesciaItaly
    95Ospedale Sandro Pertini, Uoc CardiologiaRomaItaly
    96Rijnstate Ziekenhuis - Afdeling CardioresearchArnhemNetherlands
    97Tergooi - Poli cardiologie / poli 2BlaricumNetherlands
    98Amphia Ziekenhuis - Research CardiologieBredaNetherlands
    99Jeroen Bosch Ziekenhuis - Research CardiologieDen BoschNetherlands
    100Martini Ziekenhuis - Dept. Cardio Research Noord BVGroningenNetherlands
    101Diakonessenhuis - Research CardiologieUtrechtNetherlands
    102University Medical Center Utrecht - CardiologieUtrechtNetherlands
    103Máxima Medisch Centrum - Poli CardiologieVeldhovenNetherlands
    104Prof. Doutor Fernando Fonseca EPE Hospital, CardiologiaAmadoraPortugal
    105Hospital Nossa Senhora do Rosário, CardiologyBarreiroPortugal
    106Hospital da LuzLisboaPortugal
    107Hospital de Santa Cruz, CardiologyLisboaPortugal
    108Hospital Santa Maria, CardiologyLisboaPortugal
    109Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat CoronariaBarcelonaSpain
    110Clínica Anderson, Oncología MédicaMadridSpain
    111Clínica Medicentro, CardiologíaMadridSpain
    112Hopsital Puerta de HierroMadridSpain
    113Hospital La ZarzuelaMadridSpain
    114Hospital Ramón y CajalMadridSpain
    115Hospital de Salamanca, CardiologíaSalamancaSpain
    116Hospital Universitario Virgen Macarena, CardiologiaSevillaSpain
    117Hospital de TorrejónTorrejón De ArdozSpain
    118University Clinical Hosp. de Valladolid, CardiologíaValladolidSpain
    119Hospital Clínico "Lozano Blesa", CardiologiaZaragozaSpain

    Sponsors and Collaborators

    • Heart Care Foundation

    Investigators

    • Study Chair: Michele M Gulizia, MD, Heart Care Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heart Care Foundation
    ClinicalTrials.gov Identifier:
    NCT03909386
    Other Study ID Numbers:
    • K21
    First Posted:
    Apr 10, 2019
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021