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

This study has been completed.
Sponsor:
Information provided by:
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT00421876
First received: January 12, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Resource links provided by NLM:

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00421876     History of Changes
Other Study ID Numbers: 60
Study First Received: January 12, 2007
Last Updated: January 12, 2007
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:
Infarction
Myocardial Infarction
Recurrence
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes

ClinicalTrials.gov processed this record on May 19, 2013