GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

NCT ID: NCT00421876

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Study partially sponsored by Società Prodotti Antibiotici

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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multifactorial continued educational - behavioural programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Care Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Pantaleo Giannuzzi, MD

Role: STUDY_CHAIR

Fondazione Maugeri - Veruno (NO)

Locations

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Ospedale San Donato

Arezzo, AR, Italy

Site Status

Az Osp Giuseppe Moscati

Avellino, AV, Italy

Site Status

Fondazione Salvatore Maugeri

Cassano delle Murge, BA, Italy

Site Status

Ospedale Romano di Lombardia

Romano Lombardo, BG, Italy

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Fondazione Salvatore Maugeri

Telese Terme, BN, Italy

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Ospedale Bellaria

Bologna, BO, Italy

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Presidio Gazzaniga

Gazzaniga, BS, Italy

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Fondazione Salvatore Maugeri

Gussago, BS, Italy

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Azienda Ospedaliera S Anna e S Sebastiano

Caserta, CE, Italy

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Casa di Cura Villa Pini d'Abruzzo

Chieti, CH, Italy

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Ospedale Umberto I

Bellano, Como, Italy

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Ospedale Santa Marta

Rivolta d'Adda, CR, Italy

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Ospedale Civile Minervini

Mormanno, CS, Italy

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Ospedale Civile C Chidichino

Trebisacce, CS, Italy

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Ospedale Ascoli Tomaselli

Catania, CT, Italy

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Ospedale Cannizzarro

Catania, CT, Italy

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Azienda Ospedaliera Mater Domini

Catanzaro, CZ, Italy

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Az Ospedaliera-Universitaria Careggi

Florence, FI, Italy

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Ospedale La Colletta

Arenzano, GE, Italy

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Polo Ospedaliero Rapallo S Margherita

Rapallo, GE, Italy

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ospedale Generale Provinciale

Gorizia, GO, Italy

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Ospedale San Leopoldo

Merate, Lecco, Italy

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Presidio Ospedaliero F Ferrari

Casarano, LE, Italy

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Ospedale Civile Bassa Val di Cecina

Cecina, LI, Italy

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Ospedale Civile Campo di marte

Lucca, LU, Italy

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Presidio di Riabilitazione Multifunzionale

Bozzolo, MI, Italy

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Casa di Cura Ambrosiana

Cesano Boscone, MI, Italy

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Ospedale San Gerardo

Monza, MI, Italy

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Presidio Ospedaliero di Passirana

Passirana - Rho, MI, Italy

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Fondazione Salvatore Maugeri

Tradate, MI, Italy

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Fondazione Salvatore Maugeri

Veruno, Novara, Italy

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Ospedale Buccheri la Ferla Fatebenefratelli

Palermo, PA, Italy

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Casa di Cura San Giacomo

Ponte dell'Olio, PC, Italy

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Ospedale di Camposanpiero

Camposanpiero, PD, Italy

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Predisio Ospedaliero Città di Castello

Città di Castello, PG, Italy

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Nuovo Ospedale S Giovanni Battista

Foligno, PG, Italy

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Ospedale Calai

Gualdo Tadino, PG, Italy

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Azienda Ospedaliera di Perugia

Perugia, PG, Italy

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Ex Ospedale Grocco

Perugia, PG, Italy

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ospedale della Val di Nievole

Pescia, Point, Italy

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Ospedale Civile

Sacile, Pordenone, Italy

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Fondazione Salvatore Maugeri

Montescano, PV, Italy

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Azienda Ospedaliera San Carlo

Potenza, PZ, Italy

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Casa di Cura Villa Maria Cecilia

Cotignola, RA, Italy

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Ospedale Infermi

Rimini, RA, Italy

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Policlinico Madonna della Consolazione

Reggio Calabria, RC, Italy

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Ospedale Sant'Anna

Castelnovo ne' Monti, RE, Italy

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Ospedale Civile San Sebastiano

Correggio, RE, Italy

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Ospedale E Morelli

Sondalo, SO, Italy

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Ospedale SS Annunziata

Taranto, TA, Italy

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Ospedale di ALA

Ala, TN, Italy

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Ospedale Provinciale S Pancrazio

Arco, TN, Italy

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Presidio Ospedaliero

Montebelluna, TV, Italy

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Ospedale Civile

Mirano, VE, Italy

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Ospedale Civile

San Donà di Piave, VE, Italy

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Ospedale Beauregard

Aosta, , Italy

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Ospedali Riuniti

Bergamo, , Italy

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Casa di Cura Villa Aprica

Como, , Italy

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Casa di Cura Pineta del Carso

Duino-Aurisina, , Italy

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Presidio Ospedalier S Giovanni

Mezzolombardo, , Italy

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Fondazione Don Gnocchi

Milan, , Italy

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Istituti Clinici Perfezionamento

Milan, , Italy

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Ospedale S Luca-Centro Auxologico

Milan, , Italy

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Pio Albergo Trivulzio

Milan, , Italy

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Azienda Ospedaliera Vincenzo Monaldi

Napoli, , Italy

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Policlinico Universitario Federico II

Napoli, , Italy

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Fondazione Salvatore maugeri

Pavia, , Italy

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Ospedale Forlanini

Roma, , Italy

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Ospedale Santo Spirito

Roma, , Italy

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Villa Betania

Roma, , Italy

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Ospedale Evangelico Valdese

Torino, , Italy

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Ospedale Mauriziano

Torino, , Italy

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ospedale Civile S Bortolo

Vicenza, , Italy

Site Status

Cardiocentro Ticino

Lugano, , Switzerland

Site Status

Countries

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Italy Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 16319545 (View on PubMed)

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.

Reference Type RESULT
PMID: 19001195 (View on PubMed)

Other Identifiers

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60

Identifier Type: -

Identifier Source: org_study_id

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