GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study - Full Text View

Sponsor:	Heart Care Foundation
Information provided by:	Heart Care Foundation
ClinicalTrials.gov Identifier:	NCT00421876

Purpose

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.

Condition	Intervention
Myocardial Infarction	Behavioral: multifactorial continued educational - behavioural programme

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Rehabilitation

U.S. FDA Resources

Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:

cardiovascular mortality
non fatal re-MI
angina requiring hospitalization
urgent revascularization procedures
hospitalization for heart failure
non fatal stroke

Estimated Enrollment:	3200
Study Start Date:	December 2000
Estimated Study Completion Date:	December 2005

Detailed Description:

Study partially sponsored by Società Prodotti Antibiotici

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421876

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Locations

Italy
Ospedale Mauriziano
Torino, Italy
Ospedale Evangelico Valdese
Torino, Italy
Ospedale Beauregard
Aosta, Italy
Casa di Cura Villa Aprica
Como, Italy
Istituti Clinici Perfezionamento
Milano, Italy
Pio Albergo Trivulzio
Milano, Italy
Ospedali Riuniti
Bergamo, Italy
Fondazione Don Gnocchi
Milano, Italy
Ospedale S Luca-Centro Auxologico
Milano, Italy
Azienda Ospedaliera Vincenzo Monaldi
Napoli, Italy
Presidio Ospedalier S Giovanni
Mezzolombardo, Italy
ospedale Civile S Bortolo
Vicenza, Italy
Casa di Cura Pineta del Carso
Aurisina, Italy
Ospedale Santo Spirito
Roma, Italy
Ospedale Forlanini
Roma, Italy
Villa Betania
Roma, Italy
Policlinico Universitario Federico II
Napoli, Italy
Fondazione Salvatore maugeri
Pavia, Italy
Italy, AR
Ospedale San Donato
Arezzo, AR, Italy
Italy, AV
Az Osp Giuseppe Moscati
Avellino, AV, Italy
Italy, BA
Fondazione Salvatore Maugeri
Cassano delle Murge, BA, Italy
Italy, BG
Ospedale Romano di Lombardia
Romano Lombardo, BG, Italy
Italy, BN
Fondazione Salvatore Maugeri
Telese Terme, BN, Italy
Italy, BO
Ospedale Bellaria
Bologna, BO, Italy
Italy, BS
Presidio Gazzaniga
Gazzaniga, BS, Italy
Fondazione Salvatore Maugeri
Gussago, BS, Italy
Italy, CE
Azienda Ospedaliera S Anna e S Sebastiano
Caserta, CE, Italy
Italy, CH
Casa di Cura Villa Pini d'Abruzzo
Chieti, CH, Italy
Italy, Como
Ospedale Umberto I
Bellano, Como, Italy
Italy, CR
Ospedale Santa Marta
Rivolta d'Adda, CR, Italy
Italy, CS
Ospedale Civile C Chidichino
Trebisacce, CS, Italy
Ospedale Civile Minervini
Mormanno, CS, Italy
Italy, CT
Ospedale Ascoli Tomaselli
Catania, CT, Italy
Ospedale Cannizzarro
Catania, CT, Italy
Italy, CZ
Azienda Ospedaliera Mater Domini
Catanzaro, CZ, Italy
Italy, FI
Az Ospedaliera-Universitaria Careggi
Firenze, FI, Italy
Italy, GE
Polo Ospedaliero Rapallo S Margherita
Rapallo, GE, Italy
Ospedale La Colletta
Arenzano, GE, Italy
Italy, GO
ospedale Generale Provinciale
Gorizia, GO, Italy
Italy, LE
Presidio Ospedaliero F Ferrari
Casarano, LE, Italy
Italy, Lecco
Ospedale San Leopoldo
Merate, Lecco, Italy
Italy, LI
Ospedale Civile Bassa Val di Cecina
Cecina, LI, Italy
Italy, LU
Ospedale Civile Campo di marte
Lucca, LU, Italy
Italy, MI
Ospedale San Gerardo
Monza, MI, Italy
Fondazione Salvatore Maugeri
Tradate, MI, Italy
Presidio di Riabilitazione Multifunzionale
Bozzolo, MI, Italy
Casa di Cura Ambrosiana
Cesano Boscone, MI, Italy
Presidio Ospedaliero di Passirana
Passirana - Rho, MI, Italy
Italy, Novara
Fondazione Salvatore Maugeri
Veruno, Novara, Italy
Italy, PA
Ospedale Buccheri la Ferla Fatebenefratelli
Palermo, PA, Italy
Italy, PC
Casa di Cura San Giacomo
Ponte dell'Olio, PC, Italy
Italy, PD
Ospedale di Camposanpiero
Camposanpiero, PD, Italy
Italy, PG
Ospedale Calai
Gualdo Tadino, PG, Italy
Predisio Ospedaliero Città di Castello
Città di Castello, PG, Italy
Nuovo Ospedale S Giovanni Battista
Foligno, PG, Italy
Azienda Ospedaliera di Perugia
Perugia, PG, Italy
Ex Ospedale Grocco
Perugia, PG, Italy
Italy, Pordenone
Ospedale Civile
Sacile, Pordenone, Italy
Italy, PT
ospedale della Val di Nievole
Pescia, PT, Italy
Italy, PV
Fondazione Salvatore Maugeri
Montescano, PV, Italy
Italy, PZ
Azienda Ospedaliera San Carlo
Potenza, PZ, Italy
Italy, RA
Ospedale Infermi
Rimini, RA, Italy
Casa di Cura Villa Maria Cecilia
Cotignola, RA, Italy
Italy, RC
Policlinico Madonna della Consolazione
Reggio Calabria, RC, Italy
Italy, RE
Ospedale Civile San Sebastiano
Correggio, RE, Italy
Ospedale Sant'Anna
Castelnuovo ne' Monti, RE, Italy
Italy, SO
Ospedale E Morelli
Sondalo, SO, Italy
Italy, TA
Ospedale SS Annunziata
Taranto, TA, Italy
Italy, TN
Ospedale di ALA
Ala, TN, Italy
Ospedale Provinciale S Pancrazio
Arco, TN, Italy
Italy, TV
Presidio Ospedaliero
Montebelluna, TV, Italy
Italy, VE
Ospedale Civile
Mirano, VE, Italy
Ospedale Civile
San Donà di Piave, VE, Italy
Switzerland
Cardiocentro Ticino
Lugano, Switzerland

Sponsors and Collaborators

Heart Care Foundation

Investigators

Study Chair:

Pantaleo Giannuzzi, MD

Fondazione Maugeri - Veruno (NO)

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	60
Study First Received:	January 12, 2007
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00421876 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Heart Care Foundation:

cardiac rehabilitation
lifestyle management
risk factor management
myocardial infarction
randomized trials

Additional relevant MeSH terms:

Disease Attributes
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction
Recurrence

ClinicalTrials.gov processed this record on November 27, 2009