Clinical trial NCT00421876: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Official title: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: cardiac rehabilitation
lifestyle management
risk factor management
myocardial infarction
randomized trials
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a programme of continued educational and behavioural intervention to achieve optimal long-term secondary prevention goals.

Detailed description: Study partially sponsored by Società Prodotti Antibiotici

Eligibility criteria: Inclusion Criteria:

* Recent myocardial infarction (within 3 months after the index event)
* Standard rehabilitation program of 3-6 weeks performed
* Informed consent (obtained before any study specific procedure)

Exclusion Criteria:

* Age \> 75 years
* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or be associated with poor adherence to the protocol;
* Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy

Primary outcomes:
measure: cardiovascular mortality
measure: non fatal re-MI
measure: angina requiring hospitalization
measure: urgent revascularization procedures
measure: hospitalization for heart failure
measure: non fatal stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato
state: AR
city: Avellino
country: Italy
facility: Az Osp Giuseppe Moscati
state: AV
city: Cassano delle Murge
country: Italy
facility: Fondazione Salvatore Maugeri
state: BA
city: Romano Lombardo
country: Italy
facility: Ospedale Romano di Lombardia
state: BG
city: Telese Terme
country: Italy
facility: Fondazione Salvatore Maugeri
state: BN
city: Bologna
country: Italy
facility: Ospedale Bellaria
state: BO
city: Gazzaniga
country: Italy
facility: Presidio Gazzaniga
state: BS
city: Gussago
country: Italy
facility: Fondazione Salvatore Maugeri
state: BS
city: Caserta
country: Italy
facility: Azienda Ospedaliera S Anna e S Sebastiano
state: CE
city: Chieti
country: Italy
facility: Casa di Cura Villa Pini d'Abruzzo
state: CH
city: Bellano
country: Italy
facility: Ospedale Umberto I
state: Como
city: Rivolta d'Adda
country: Italy
facility: Ospedale Santa Marta
state: CR
city: Mormanno
country: Italy
facility: Ospedale Civile Minervini
state: CS
city: Trebisacce
country: Italy
facility: Ospedale Civile C Chidichino
state: CS
city: Catania
country: Italy
facility: Ospedale Ascoli Tomaselli
state: CT
city: Catania
country: Italy
facility: Ospedale Cannizzarro
state: CT
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
state: CZ
city: Firenze
country: Italy
facility: Az Ospedaliera-Universitaria Careggi
state: FI
city: Arenzano
country: Italy
facility: Ospedale La Colletta
state: GE
city: Rapallo
country: Italy
facility: Polo Ospedaliero Rapallo S Margherita
state: GE
city: Gorizia
country: Italy
facility: ospedale Generale Provinciale
state: GO
city: Merate
country: Italy
facility: Ospedale San Leopoldo
state: Lecco
city: Casarano
country: Italy
facility: Presidio Ospedaliero F Ferrari
state: LE
city: Cecina
country: Italy
facility: Ospedale Civile Bassa Val di Cecina
state: LI
city: Lucca
country: Italy
facility: Ospedale Civile Campo di marte
state: LU
city: Bozzolo
country: Italy
facility: Presidio di Riabilitazione Multifunzionale
state: MI
city: Cesano Boscone
country: Italy
facility: Casa di Cura Ambrosiana
state: MI
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: MI
city: Passirana - Rho
country: Italy
facility: Presidio Ospedaliero di Passirana
state: MI
city: Tradate
country: Italy
facility: Fondazione Salvatore Maugeri
state: MI
city: Veruno
country: Italy
facility: Fondazione Salvatore Maugeri
state: Novara
city: Palermo
country: Italy
facility: Ospedale Buccheri la Ferla Fatebenefratelli
state: PA
city: Ponte dell'Olio
country: Italy
facility: Casa di Cura San Giacomo
state: PC
city: Camposanpiero
country: Italy
facility: Ospedale di Camposanpiero
state: PD
city: Città di Castello
country: Italy
facility: Predisio Ospedaliero Città di Castello
state: PG
city: Foligno
country: Italy
facility: Nuovo Ospedale S Giovanni Battista
state: PG
city: Gualdo Tadino
country: Italy
facility: Ospedale Calai
state: PG
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
state: PG
city: Perugia
country: Italy
facility: Ex Ospedale Grocco
state: PG
city: Pescia
country: Italy
facility: ospedale della Val di Nievole
state: Point
city: Sacile
country: Italy
facility: Ospedale Civile
state: Pordenone
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri
state: PV
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo
state: PZ
city: Cotignola
country: Italy
facility: Casa di Cura Villa Maria Cecilia
state: RA
city: Rimini
country: Italy
facility: Ospedale Infermi
state: RA
city: Reggio Calabria
country: Italy
facility: Policlinico Madonna della Consolazione
state: RC
city: Castelnuovo Ne' Monti
country: Italy
facility: Ospedale Sant'Anna
state: RE
city: Correggio
country: Italy
facility: Ospedale Civile San Sebastiano
state: RE
city: Sondalo
country: Italy
facility: Ospedale E Morelli
state: SO
city: Taranto
country: Italy
facility: Ospedale SS Annunziata
state: TA
city: Ala
country: Italy
facility: Ospedale di ALA
state: TN
city: Arco
country: Italy
facility: Ospedale Provinciale S Pancrazio
state: TN
city: Montebelluna
country: Italy
facility: Presidio Ospedaliero
state: TV
city: Mirano
country: Italy
facility: Ospedale Civile
state: VE
city: San Donà di Piave
country: Italy
facility: Ospedale Civile
state: VE
city: Aosta
country: Italy
facility: Ospedale Beauregard
city: Aurisina
country: Italy
facility: Casa di Cura Pineta del Carso
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Como
country: Italy
facility: Casa di Cura Villa Aprica
city: Mezzolombardo
country: Italy
facility: Presidio Ospedalier S Giovanni
city: Milano
country: Italy
facility: Fondazione Don Gnocchi
city: Milano
country: Italy
facility: Istituti Clinici Perfezionamento
city: Milano
country: Italy
facility: Ospedale S Luca-Centro Auxologico
city: Milano
country: Italy
facility: Pio Albergo Trivulzio
city: Napoli
country: Italy
facility: Azienda Ospedaliera Vincenzo Monaldi
city: Napoli
country: Italy
facility: Policlinico Universitario Federico II
city: Pavia
country: Italy
facility: Fondazione Salvatore maugeri
city: Roma
country: Italy
facility: Ospedale Forlanini
city: Roma
country: Italy
facility: Ospedale Santo Spirito
city: Roma
country: Italy
facility: Villa Betania
city: Torino
country: Italy
facility: Ospedale Evangelico Valdese
city: Torino
country: Italy
facility: Ospedale Mauriziano
city: Vicenza
country: Italy
facility: ospedale Civile S Bortolo
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
Study officials:
affiliation: Fondazione Maugeri - Veruno (NO)
name: Pantaleo Giannuzzi, MD
role: STUDY_CHAIR
References:
citation: Giannuzzi P, Temporelli PL, Maggioni AP, Ceci V, Chieffo C, Gattone M, Griffo R, Marchioli R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F; GOSPEL. GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction: the GOSPEL study. A trial from the Italian Cardiac Rehabilitation Network: rationale and design. Eur J Cardiovasc Prev Rehabil. 2005 Dec;12(6):555-61. doi: 10.1097/01.hjr.0000186623.60486.26.
citation: Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D; GOSPEL Investigators. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008 Nov 10;168(20):2194-204. doi: 10.1001/archinte.168.20.2194.