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

Myocardial Infarction

Intervention / Treatment

Behavioral: multifactorial continued educational - behavioural programme

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

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

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

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
cardiovascular mortality
non fatal re-MI
angina requiring hospitalization
urgent revascularization procedures
hospitalization for heart failure
non fatal stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

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

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

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.