Myocardial InfarctionNCT00421876
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
A study testing multifactorial continued educational - behavioural programme in people with Myocardial Infarction, run by Heart Care Foundation at 74 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- multifactorial continued educational - behavioural programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,200 participants
- Where
- 74 sitesin 2 countries
- Study dates
- Dec 2000to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
74 sites in 2 countries.
74 sites in 2 countries
Italy73 sites
Ospedale di ALA
Ala, TN
Ospedale Beauregard
Aosta
Ospedale Provinciale S Pancrazio
Arco, TN
Ospedale La Colletta
Arenzano, GE
Ospedale San Donato
Arezzo, AR
Az Osp Giuseppe Moscati
Avellino, AV
Ospedale Umberto I
Bellano, Como
Ospedali Riuniti
Bergamo
Ospedale Bellaria
Bologna, BO
Presidio di Riabilitazione Multifunzionale
Bozzolo, MI
Ospedale di Camposanpiero
Camposanpiero, PD
Presidio Ospedaliero F Ferrari
Casarano, LE
Azienda Ospedaliera S Anna e S Sebastiano
Caserta, CE
Fondazione Salvatore Maugeri
Cassano delle Murge, BA
Ospedale Sant'Anna
Castelnovo ne' Monti, RE
Ospedale Ascoli Tomaselli
Catania, CT
Ospedale Cannizzarro
Catania, CT
Azienda Ospedaliera Mater Domini
Catanzaro, CZ
Ospedale Civile Bassa Val di Cecina
Cecina, LI
Casa di Cura Ambrosiana
Cesano Boscone, MI
Casa di Cura Villa Pini d'Abruzzo
Chieti, CH
Predisio Ospedaliero Città di Castello
Città di Castello, PG
Casa di Cura Villa Aprica
Como
Ospedale Civile San Sebastiano
Correggio, RE
Casa di Cura Villa Maria Cecilia
Cotignola, RA
Casa di Cura Pineta del Carso
Duino-Aurisina
Az Ospedaliera-Universitaria Careggi
Florence, FI
Nuovo Ospedale S Giovanni Battista
Foligno, PG
Presidio Gazzaniga
Gazzaniga, BS
ospedale Generale Provinciale
Gorizia, GO
Ospedale Calai
Gualdo Tadino, PG
Fondazione Salvatore Maugeri
Gussago, BS
Ospedale Civile Campo di marte
Lucca, LU
Ospedale San Leopoldo
Merate, Lecco
Presidio Ospedalier S Giovanni
Mezzolombardo
Fondazione Don Gnocchi
Milan
Istituti Clinici Perfezionamento
Milan
Ospedale S Luca-Centro Auxologico
Milan
Pio Albergo Trivulzio
Milan
Ospedale Civile
Mirano, VE
Presidio Ospedaliero
Montebelluna, TV
Fondazione Salvatore Maugeri
Montescano, PV
Ospedale San Gerardo
Monza, MI
Ospedale Civile Minervini
Mormanno, CS
Azienda Ospedaliera Vincenzo Monaldi
Naples
Policlinico Universitario Federico II
Naples
Ospedale Buccheri la Ferla Fatebenefratelli
Palermo, PA
Presidio Ospedaliero di Passirana
Passirana - Rho, MI
Fondazione Salvatore maugeri
Pavia
Azienda Ospedaliera di Perugia
Perugia, PG
Ex Ospedale Grocco
Perugia, PG
ospedale della Val di Nievole
Pescia, Point
Casa di Cura San Giacomo
Ponte dell'Olio, PC
Azienda Ospedaliera San Carlo
Potenza, PZ
Polo Ospedaliero Rapallo S Margherita
Rapallo, GE
Policlinico Madonna della Consolazione
Reggio Calabria, RC
Ospedale Infermi
Rimini, RA
Ospedale Santa Marta
Rivolta d'Adda, CR
Ospedale Forlanini
Roma
Ospedale Santo Spirito
Roma
Villa Betania
Roma
Ospedale Romano di Lombardia
Romano Lombardo, BG
Ospedale Civile
Sacile, Pordenone
Ospedale Civile
San Donà di Piave, VE
Ospedale E Morelli
Sondalo, SO
Ospedale SS Annunziata
Taranto, TA
Fondazione Salvatore Maugeri
Telese Terme, BN
Ospedale Evangelico Valdese
Torino
Ospedale Mauriziano
Torino
Fondazione Salvatore Maugeri
Tradate, MI
Ospedale Civile C Chidichino
Trebisacce, CS
Fondazione Salvatore Maugeri
Veruno, Novara
ospedale Civile S Bortolo
Vicenza
About this study
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.
Read the detailed description
Study partially sponsored by Società Prodotti Antibiotici
- Conditions
- Myocardial Infarction
- Being tested
- multifactorial continued educational - behavioural programme
- Keywords
- cardiac rehabilitation, lifestyle management, risk factor management, myocardial infarction, randomized trials
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifactorial continued educational - behavioural programmeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular mortality
non fatal re-MI
angina requiring hospitalization
urgent revascularization procedures
hospitalization for heart failure
non fatal stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startDec 2000
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,200 participants
Sponsor and investigators
- Lead sponsor
- Heart Care Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Pantaleo Giannuzzi, MD, Study chair, Fondazione Maugeri - Veruno (NO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421876
- Sponsor's protocol ID
- 60
- Status last verified
- Jan 2007
- First submitted
- 12 Jan 2007
- Last updated
- 3 Feb 2021
- Results posted
- No
Publications
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.
PubMed 16319545Giannuzzi 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.
PubMed 19001195
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
- ClinicalTrials.gov ID
- NCT00421876
- Acronym / sponsor ID
- 60
- Conditions
- Myocardial Infarction
- Keywords
- cardiac rehabilitation, lifestyle management, risk factor management, myocardial infarction, randomized trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,200 participants
- Lead sponsor
- Heart Care FoundationUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Dec 2005
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study partially sponsored by Società Prodotti Antibiotici
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multifactorial continued educational - behavioural programme | Behavioural | – |
Primary outcome
cardiovascular mortality
non fatal re-MI
angina requiring hospitalization
urgent revascularization procedures
hospitalization for heart failure
non fatal stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 16319545Giannuzzi 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.
- Results publication: PubMed 19001195Giannuzzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pantaleo Giannuzzi, MD study chair
Fondazione Maugeri - Veruno (NO)
74 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multifactorial continued educational - behavioural programme in people with Myocardial Infarction, run by Heart Care Foundation at 74 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular mortality. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421876, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.