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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
multifactorial continued educational - behavioural programme
Sponsored by
Heart Care Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction focused on measuring cardiac rehabilitation, lifestyle management, risk factor management, myocardial infarction, randomized trials

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale San Donato
  • Az Osp Giuseppe Moscati
  • Fondazione Salvatore Maugeri
  • Ospedale Romano di Lombardia
  • Fondazione Salvatore Maugeri
  • Ospedale Bellaria
  • Presidio Gazzaniga
  • Fondazione Salvatore Maugeri
  • Azienda Ospedaliera S Anna e S Sebastiano
  • Casa di Cura Villa Pini d'Abruzzo
  • Ospedale Umberto I
  • Ospedale Santa Marta
  • Ospedale Civile Minervini
  • Ospedale Civile C Chidichino
  • Ospedale Ascoli Tomaselli
  • Ospedale Cannizzarro
  • Azienda Ospedaliera Mater Domini
  • Az Ospedaliera-Universitaria Careggi
  • Ospedale La Colletta
  • Polo Ospedaliero Rapallo S Margherita
  • ospedale Generale Provinciale
  • Ospedale San Leopoldo
  • Presidio Ospedaliero F Ferrari
  • Ospedale Civile Bassa Val di Cecina
  • Ospedale Civile Campo di marte
  • Presidio di Riabilitazione Multifunzionale
  • Casa di Cura Ambrosiana
  • Ospedale San Gerardo
  • Presidio Ospedaliero di Passirana
  • Fondazione Salvatore Maugeri
  • Fondazione Salvatore Maugeri
  • Ospedale Buccheri la Ferla Fatebenefratelli
  • Casa di Cura San Giacomo
  • Ospedale di Camposanpiero
  • Predisio Ospedaliero Città di Castello
  • Nuovo Ospedale S Giovanni Battista
  • Ospedale Calai
  • Azienda Ospedaliera di Perugia
  • Ex Ospedale Grocco
  • ospedale della Val di Nievole
  • Ospedale Civile
  • Fondazione Salvatore Maugeri
  • Azienda Ospedaliera San Carlo
  • Casa di Cura Villa Maria Cecilia
  • Ospedale Infermi
  • Policlinico Madonna della Consolazione
  • Ospedale Sant'Anna
  • Ospedale Civile San Sebastiano
  • Ospedale E Morelli
  • Ospedale SS Annunziata
  • Ospedale di ALA
  • Ospedale Provinciale S Pancrazio
  • Presidio Ospedaliero
  • Ospedale Civile
  • Ospedale Civile
  • Ospedale Beauregard
  • Casa di Cura Pineta del Carso
  • Ospedali Riuniti
  • Casa di Cura Villa Aprica
  • Presidio Ospedalier S Giovanni
  • Fondazione Don Gnocchi
  • Istituti Clinici Perfezionamento
  • Ospedale S Luca-Centro Auxologico
  • Pio Albergo Trivulzio
  • Azienda Ospedaliera Vincenzo Monaldi
  • Policlinico Universitario Federico II
  • Fondazione Salvatore maugeri
  • Ospedale Forlanini
  • Ospedale Santo Spirito
  • Villa Betania
  • Ospedale Evangelico Valdese
  • Ospedale Mauriziano
  • ospedale Civile S Bortolo
  • Cardiocentro Ticino

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2007
Last Updated
February 2, 2021
Sponsor
Heart Care Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00421876
Brief Title
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Official Title
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heart Care Foundation

4. Oversight

5. Study Description

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.
Detailed Description
Study partially sponsored by Società Prodotti Antibiotici

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
cardiac rehabilitation, lifestyle management, risk factor management, myocardial infarction, randomized trials

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
multifactorial continued educational - behavioural programme
Primary Outcome Measure Information:
Title
cardiovascular mortality
Title
non fatal re-MI
Title
angina requiring hospitalization
Title
urgent revascularization procedures
Title
hospitalization for heart failure
Title
non fatal stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pantaleo Giannuzzi, MD
Organizational Affiliation
Fondazione Maugeri - Veruno (NO)
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale San Donato
City
Arezzo
State/Province
AR
Country
Italy
Facility Name
Az Osp Giuseppe Moscati
City
Avellino
State/Province
AV
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Cassano delle Murge
State/Province
BA
Country
Italy
Facility Name
Ospedale Romano di Lombardia
City
Romano Lombardo
State/Province
BG
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Telese Terme
State/Province
BN
Country
Italy
Facility Name
Ospedale Bellaria
City
Bologna
State/Province
BO
Country
Italy
Facility Name
Presidio Gazzaniga
City
Gazzaniga
State/Province
BS
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Gussago
State/Province
BS
Country
Italy
Facility Name
Azienda Ospedaliera S Anna e S Sebastiano
City
Caserta
State/Province
CE
Country
Italy
Facility Name
Casa di Cura Villa Pini d'Abruzzo
City
Chieti
State/Province
CH
Country
Italy
Facility Name
Ospedale Umberto I
City
Bellano
State/Province
Como
Country
Italy
Facility Name
Ospedale Santa Marta
City
Rivolta d'Adda
State/Province
CR
Country
Italy
Facility Name
Ospedale Civile Minervini
City
Mormanno
State/Province
CS
Country
Italy
Facility Name
Ospedale Civile C Chidichino
City
Trebisacce
State/Province
CS
Country
Italy
Facility Name
Ospedale Ascoli Tomaselli
City
Catania
State/Province
CT
Country
Italy
Facility Name
Ospedale Cannizzarro
City
Catania
State/Province
CT
Country
Italy
Facility Name
Azienda Ospedaliera Mater Domini
City
Catanzaro
State/Province
CZ
Country
Italy
Facility Name
Az Ospedaliera-Universitaria Careggi
City
Firenze
State/Province
FI
Country
Italy
Facility Name
Ospedale La Colletta
City
Arenzano
State/Province
GE
Country
Italy
Facility Name
Polo Ospedaliero Rapallo S Margherita
City
Rapallo
State/Province
GE
Country
Italy
Facility Name
ospedale Generale Provinciale
City
Gorizia
State/Province
GO
Country
Italy
Facility Name
Ospedale San Leopoldo
City
Merate
State/Province
Lecco
Country
Italy
Facility Name
Presidio Ospedaliero F Ferrari
City
Casarano
State/Province
LE
Country
Italy
Facility Name
Ospedale Civile Bassa Val di Cecina
City
Cecina
State/Province
LI
Country
Italy
Facility Name
Ospedale Civile Campo di marte
City
Lucca
State/Province
LU
Country
Italy
Facility Name
Presidio di Riabilitazione Multifunzionale
City
Bozzolo
State/Province
MI
Country
Italy
Facility Name
Casa di Cura Ambrosiana
City
Cesano Boscone
State/Province
MI
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
State/Province
MI
Country
Italy
Facility Name
Presidio Ospedaliero di Passirana
City
Passirana - Rho
State/Province
MI
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Tradate
State/Province
MI
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Veruno
State/Province
Novara
Country
Italy
Facility Name
Ospedale Buccheri la Ferla Fatebenefratelli
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Casa di Cura San Giacomo
City
Ponte dell'Olio
State/Province
PC
Country
Italy
Facility Name
Ospedale di Camposanpiero
City
Camposanpiero
State/Province
PD
Country
Italy
Facility Name
Predisio Ospedaliero Città di Castello
City
Città di Castello
State/Province
PG
Country
Italy
Facility Name
Nuovo Ospedale S Giovanni Battista
City
Foligno
State/Province
PG
Country
Italy
Facility Name
Ospedale Calai
City
Gualdo Tadino
State/Province
PG
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia
City
Perugia
State/Province
PG
Country
Italy
Facility Name
Ex Ospedale Grocco
City
Perugia
State/Province
PG
Country
Italy
Facility Name
ospedale della Val di Nievole
City
Pescia
State/Province
Point
Country
Italy
Facility Name
Ospedale Civile
City
Sacile
State/Province
Pordenone
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Montescano
State/Province
PV
Country
Italy
Facility Name
Azienda Ospedaliera San Carlo
City
Potenza
State/Province
PZ
Country
Italy
Facility Name
Casa di Cura Villa Maria Cecilia
City
Cotignola
State/Province
RA
Country
Italy
Facility Name
Ospedale Infermi
City
Rimini
State/Province
RA
Country
Italy
Facility Name
Policlinico Madonna della Consolazione
City
Reggio Calabria
State/Province
RC
Country
Italy
Facility Name
Ospedale Sant'Anna
City
Castelnuovo Ne' Monti
State/Province
RE
Country
Italy
Facility Name
Ospedale Civile San Sebastiano
City
Correggio
State/Province
RE
Country
Italy
Facility Name
Ospedale E Morelli
City
Sondalo
State/Province
SO
Country
Italy
Facility Name
Ospedale SS Annunziata
City
Taranto
State/Province
TA
Country
Italy
Facility Name
Ospedale di ALA
City
Ala
State/Province
TN
Country
Italy
Facility Name
Ospedale Provinciale S Pancrazio
City
Arco
State/Province
TN
Country
Italy
Facility Name
Presidio Ospedaliero
City
Montebelluna
State/Province
TV
Country
Italy
Facility Name
Ospedale Civile
City
Mirano
State/Province
VE
Country
Italy
Facility Name
Ospedale Civile
City
San Donà di Piave
State/Province
VE
Country
Italy
Facility Name
Ospedale Beauregard
City
Aosta
Country
Italy
Facility Name
Casa di Cura Pineta del Carso
City
Aurisina
Country
Italy
Facility Name
Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
Casa di Cura Villa Aprica
City
Como
Country
Italy
Facility Name
Presidio Ospedalier S Giovanni
City
Mezzolombardo
Country
Italy
Facility Name
Fondazione Don Gnocchi
City
Milano
Country
Italy
Facility Name
Istituti Clinici Perfezionamento
City
Milano
Country
Italy
Facility Name
Ospedale S Luca-Centro Auxologico
City
Milano
Country
Italy
Facility Name
Pio Albergo Trivulzio
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Vincenzo Monaldi
City
Napoli
Country
Italy
Facility Name
Policlinico Universitario Federico II
City
Napoli
Country
Italy
Facility Name
Fondazione Salvatore maugeri
City
Pavia
Country
Italy
Facility Name
Ospedale Forlanini
City
Roma
Country
Italy
Facility Name
Ospedale Santo Spirito
City
Roma
Country
Italy
Facility Name
Villa Betania
City
Roma
Country
Italy
Facility Name
Ospedale Evangelico Valdese
City
Torino
Country
Italy
Facility Name
Ospedale Mauriziano
City
Torino
Country
Italy
Facility Name
ospedale Civile S Bortolo
City
Vicenza
Country
Italy
Facility Name
Cardiocentro Ticino
City
Lugano
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16319545
Citation
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.
Results Reference
background
PubMed Identifier
19001195
Citation
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.
Results Reference
result

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

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