NCT00421876

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable

Geographic Reach
2 countries

74 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2007

First QC Date

January 12, 2007

Last Update Submit

February 2, 2021

Conditions

Keywords

cardiac rehabilitationlifestyle managementrisk factor managementmyocardial infarctionrandomized trials

Outcome Measures

Primary Outcomes (6)

  • cardiovascular mortality

  • non fatal re-MI

  • angina requiring hospitalization

  • urgent revascularization procedures

  • hospitalization for heart failure

  • non fatal stroke

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (74)

Ospedale San Donato

Arezzo, AR, Italy

Location

Az Osp Giuseppe Moscati

Avellino, AV, Italy

Location

Fondazione Salvatore Maugeri

Cassano delle Murge, BA, Italy

Location

Ospedale Romano di Lombardia

Romano Lombardo, BG, Italy

Location

Fondazione Salvatore Maugeri

Telese Terme, BN, Italy

Location

Ospedale Bellaria

Bologna, BO, Italy

Location

Presidio Gazzaniga

Gazzaniga, BS, Italy

Location

Fondazione Salvatore Maugeri

Gussago, BS, Italy

Location

Azienda Ospedaliera S Anna e S Sebastiano

Caserta, CE, Italy

Location

Casa di Cura Villa Pini d'Abruzzo

Chieti, CH, Italy

Location

Ospedale Umberto I

Bellano, Como, Italy

Location

Ospedale Santa Marta

Rivolta d'Adda, CR, Italy

Location

Ospedale Civile Minervini

Mormanno, CS, Italy

Location

Ospedale Civile C Chidichino

Trebisacce, CS, Italy

Location

Ospedale Ascoli Tomaselli

Catania, CT, Italy

Location

Ospedale Cannizzarro

Catania, CT, Italy

Location

Azienda Ospedaliera Mater Domini

Catanzaro, CZ, Italy

Location

Az Ospedaliera-Universitaria Careggi

Florence, FI, Italy

Location

Ospedale La Colletta

Arenzano, GE, Italy

Location

Polo Ospedaliero Rapallo S Margherita

Rapallo, GE, Italy

Location

ospedale Generale Provinciale

Gorizia, GO, Italy

Location

Ospedale San Leopoldo

Merate, Lecco, Italy

Location

Presidio Ospedaliero F Ferrari

Casarano, LE, Italy

Location

Ospedale Civile Bassa Val di Cecina

Cecina, LI, Italy

Location

Ospedale Civile Campo di marte

Lucca, LU, Italy

Location

Presidio di Riabilitazione Multifunzionale

Bozzolo, MI, Italy

Location

Casa di Cura Ambrosiana

Cesano Boscone, MI, Italy

Location

Ospedale San Gerardo

Monza, MI, Italy

Location

Presidio Ospedaliero di Passirana

Passirana - Rho, MI, Italy

Location

Fondazione Salvatore Maugeri

Tradate, MI, Italy

Location

Fondazione Salvatore Maugeri

Veruno, Novara, Italy

Location

Ospedale Buccheri la Ferla Fatebenefratelli

Palermo, PA, Italy

Location

Casa di Cura San Giacomo

Ponte dell'Olio, PC, Italy

Location

Ospedale di Camposanpiero

Camposanpiero, PD, Italy

Location

Predisio Ospedaliero Città di Castello

Città di Castello, PG, Italy

Location

Nuovo Ospedale S Giovanni Battista

Foligno, PG, Italy

Location

Ospedale Calai

Gualdo Tadino, PG, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, PG, Italy

Location

Ex Ospedale Grocco

Perugia, PG, Italy

Location

ospedale della Val di Nievole

Pescia, Point, Italy

Location

Ospedale Civile

Sacile, Pordenone, Italy

Location

Fondazione Salvatore Maugeri

Montescano, PV, Italy

Location

Azienda Ospedaliera San Carlo

Potenza, PZ, Italy

Location

Casa di Cura Villa Maria Cecilia

Cotignola, RA, Italy

Location

Ospedale Infermi

Rimini, RA, Italy

Location

Policlinico Madonna della Consolazione

Reggio Calabria, RC, Italy

Location

Ospedale Sant'Anna

Castelnovo ne' Monti, RE, Italy

Location

Ospedale Civile San Sebastiano

Correggio, RE, Italy

Location

Ospedale E Morelli

Sondalo, SO, Italy

Location

Ospedale SS Annunziata

Taranto, TA, Italy

Location

Ospedale di ALA

Ala, TN, Italy

Location

Ospedale Provinciale S Pancrazio

Arco, TN, Italy

Location

Presidio Ospedaliero

Montebelluna, TV, Italy

Location

Ospedale Civile

Mirano, VE, Italy

Location

Ospedale Civile

San Donà di Piave, VE, Italy

Location

Ospedale Beauregard

Aosta, Italy

Location

Ospedali Riuniti

Bergamo, Italy

Location

Casa di Cura Villa Aprica

Como, Italy

Location

Casa di Cura Pineta del Carso

Duino-Aurisina, Italy

Location

Presidio Ospedalier S Giovanni

Mezzolombardo, Italy

Location

Fondazione Don Gnocchi

Milan, Italy

Location

Istituti Clinici Perfezionamento

Milan, Italy

Location

Ospedale S Luca-Centro Auxologico

Milan, Italy

Location

Pio Albergo Trivulzio

Milan, Italy

Location

Azienda Ospedaliera Vincenzo Monaldi

Napoli, Italy

Location

Policlinico Universitario Federico II

Napoli, Italy

Location

Fondazione Salvatore maugeri

Pavia, Italy

Location

Ospedale Forlanini

Roma, Italy

Location

Ospedale Santo Spirito

Roma, Italy

Location

Villa Betania

Roma, Italy

Location

Ospedale Evangelico Valdese

Torino, Italy

Location

Ospedale Mauriziano

Torino, Italy

Location

ospedale Civile S Bortolo

Vicenza, Italy

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

Related 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. doi: 10.1097/01.hjr.0000186623.60486.26.

    PMID: 16319545BACKGROUND
  • 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.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Pantaleo Giannuzzi, MD

    Fondazione Maugeri - Veruno (NO)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 15, 2007

Study Start

December 1, 2000

Study Completion

December 1, 2005

Last Updated

February 3, 2021

Record last verified: 2007-01

Locations