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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00421876
Other study ID # 60
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2000
Est. completion date December 2005

Study information

Verified date January 2007
Source Heart Care Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Study partially sponsored by Società Prodotti Antibiotici


Recruitment information / eligibility

Status Completed
Enrollment 3200
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
multifactorial continued educational - behavioural programme


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Heart Care Foundation

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary cardiovascular mortality
Primary non fatal re-MI
Primary angina requiring hospitalization
Primary urgent revascularization procedures
Primary hospitalization for heart failure
Primary non fatal stroke
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