Myocardial Infarction Clinical Trial
Official title:
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
| 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 |
| Verified date | January 2007 |
| Source | Heart Care Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Heart Care Foundation |
Italy, Switzerland,
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
| 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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