- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00421876
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
February 2, 2021 updated by: Heart Care Foundation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study partially sponsored by Società Prodotti Antibiotici
Study Type
Interventional
Enrollment
3200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aosta, Italy
- Ospedale Beauregard
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Aurisina, Italy
- Casa di Cura Pineta del Carso
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Bergamo, Italy
- Ospedali Riuniti
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Como, Italy
- Casa di Cura Villa Aprica
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Mezzolombardo, Italy
- Presidio Ospedalier S Giovanni
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Milano, Italy
- Fondazione Don Gnocchi
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Milano, Italy
- Istituti Clinici Perfezionamento
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Milano, Italy
- Ospedale S Luca-Centro Auxologico
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Milano, Italy
- Pio Albergo Trivulzio
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Napoli, Italy
- Policlinico Universitario Federico II
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Napoli, Italy
- Azienda Ospedaliera Vincenzo Monaldi
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Pavia, Italy
- Fondazione Salvatore Maugeri
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Roma, Italy
- Ospedale Santo Spirito
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Roma, Italy
- Ospedale Forlanini
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Roma, Italy
- Villa Betania
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Torino, Italy
- Ospedale Evangelico Valdese
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Torino, Italy
- Ospedale Mauriziano
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Vicenza, Italy
- ospedale Civile S Bortolo
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AR
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Arezzo, AR, Italy
- Ospedale San Donato
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AV
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Avellino, AV, Italy
- Az Osp Giuseppe Moscati
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BA
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Cassano delle Murge, BA, Italy
- Fondazione Salvatore Maugeri
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BG
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Romano Lombardo, BG, Italy
- Ospedale Romano di Lombardia
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BN
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Telese Terme, BN, Italy
- Fondazione Salvatore Maugeri
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BO
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Bologna, BO, Italy
- Ospedale Bellaria
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BS
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Gazzaniga, BS, Italy
- Presidio Gazzaniga
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Gussago, BS, Italy
- Fondazione Salvatore Maugeri
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CE
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Caserta, CE, Italy
- Azienda Ospedaliera S Anna e S Sebastiano
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CH
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Chieti, CH, Italy
- Casa di Cura Villa Pini d'Abruzzo
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CR
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Rivolta d'Adda, CR, Italy
- Ospedale Santa Marta
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CS
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Mormanno, CS, Italy
- Ospedale Civile Minervini
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Trebisacce, CS, Italy
- Ospedale Civile C Chidichino
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CT
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Catania, CT, Italy
- Ospedale Ascoli Tomaselli
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Catania, CT, Italy
- Ospedale Cannizzarro
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CZ
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Catanzaro, CZ, Italy
- Azienda Ospedaliera Mater Domini
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Como
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Bellano, Como, Italy
- Ospedale Umberto I
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FI
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Firenze, FI, Italy
- Az Ospedaliera-Universitaria Careggi
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GE
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Arenzano, GE, Italy
- Ospedale La Colletta
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Rapallo, GE, Italy
- Polo Ospedaliero Rapallo S Margherita
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GO
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Gorizia, GO, Italy
- Ospedale Generale provinciale
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LE
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Casarano, LE, Italy
- Presidio Ospedaliero F Ferrari
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LI
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Cecina, LI, Italy
- Ospedale Civile Bassa Val di Cecina
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LU
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Lucca, LU, Italy
- Ospedale Civile Campo di Marte
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Lecco
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Merate, Lecco, Italy
- Ospedale San Leopoldo
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MI
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Bozzolo, MI, Italy
- Presidio di Riabilitazione Multifunzionale
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Cesano Boscone, MI, Italy
- Casa di Cura Ambrosiana
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Monza, MI, Italy
- Ospedale San Gerardo
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Passirana - Rho, MI, Italy
- Presidio Ospedaliero di Passirana
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Tradate, MI, Italy
- Fondazione Salvatore Maugeri
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Novara
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Veruno, Novara, Italy
- Fondazione Salvatore Maugeri
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PA
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Palermo, PA, Italy
- Ospedale Buccheri La Ferla Fatebenefratelli
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PC
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Ponte dell'Olio, PC, Italy
- Casa di Cura San Giacomo
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PD
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Camposanpiero, PD, Italy
- Ospedale di Camposanpiero
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PG
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Città di Castello, PG, Italy
- Predisio Ospedaliero Città di Castello
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Foligno, PG, Italy
- Nuovo Ospedale S Giovanni Battista
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Gualdo Tadino, PG, Italy
- Ospedale Calai
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Perugia, PG, Italy
- Azienda Ospedaliera di Perugia
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Perugia, PG, Italy
- Ex Ospedale Grocco
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PV
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Montescano, PV, Italy
- Fondazione Salvatore Maugeri
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PZ
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Potenza, PZ, Italy
- Azienda Ospedaliera San Carlo
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Point
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Pescia, Point, Italy
- ospedale della Val di Nievole
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Pordenone
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Sacile, Pordenone, Italy
- Ospedale Civile
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RA
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Cotignola, RA, Italy
- Casa di Cura Villa Maria Cecilia
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Rimini, RA, Italy
- Ospedale Infermi
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RC
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Reggio Calabria, RC, Italy
- Policlinico Madonna della Consolazione
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RE
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Castelnuovo Ne' Monti, RE, Italy
- Ospedale Sant'Anna
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Correggio, RE, Italy
- Ospedale Civile San Sebastiano
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SO
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Sondalo, SO, Italy
- Ospedale E Morelli
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TA
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Taranto, TA, Italy
- Ospedale SS Annunziata
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TN
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Ala, TN, Italy
- Ospedale di ALA
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Arco, TN, Italy
- Ospedale Provinciale S Pancrazio
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TV
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Montebelluna, TV, Italy
- Presidio Ospedaliero
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VE
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Mirano, VE, Italy
- Ospedale Civile
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San Donà di Piave, VE, Italy
- Ospedale Civile
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Lugano, Switzerland
- Cardiocentro Ticino
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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cardiovascular mortality
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non fatal re-MI
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angina requiring hospitalization
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urgent revascularization procedures
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hospitalization for heart failure
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non fatal stroke
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pantaleo Giannuzzi, MD, Fondazione Maugeri - Veruno (NO)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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