GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study - Full Text View

Sponsor:	Heart Care Foundation
Information provided by:	Heart Care Foundation
ClinicalTrials.gov Identifier:	NCT00421876

Purpose

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.

Condition	Intervention
Myocardial Infarction	Behavioral: multifactorial continued educational - behavioural programme

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Rehabilitation

U.S. FDA Resources

Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:

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

Estimated Enrollment:	3200
Study Start Date:	December 2000
Estimated Study Completion Date:	December 2005

Detailed Description:

Study partially sponsored by Società Prodotti Antibiotici

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421876

Show 74 Study Locations

Sponsors and Collaborators

Heart Care Foundation

Investigators

Study Chair:

Pantaleo Giannuzzi, MD

Fondazione Maugeri - Veruno (NO)

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	60
Study First Received:	January 12, 2007
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00421876 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Heart Care Foundation:

cardiac rehabilitation
lifestyle management
risk factor management
myocardial infarction
randomized trials

Additional relevant MeSH terms:

Disease Attributes
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction
Recurrence

ClinicalTrials.gov processed this record on November 20, 2009