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

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ClinicalTrials.gov Identifier: NCT00421876
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : January 15, 2007
Sponsor:
Information provided by:
Heart Care Foundation

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Behavioral: multifactorial continued educational - behavioural programme Not Applicable

Detailed Description:
Study partially sponsored by Società Prodotti Antibiotici

Study Type : Interventional  (Clinical Trial)
Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Study Start Date : December 2000
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources




Primary Outcome Measures :
  1. cardiovascular mortality
  2. non fatal re-MI
  3. angina requiring hospitalization
  4. urgent revascularization procedures
  5. hospitalization for heart failure
  6. non fatal stroke


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421876


  Show 74 Study Locations
Sponsors and Collaborators
Heart Care Foundation
Investigators
Study Chair: Pantaleo Giannuzzi, MD Fondazione Maugeri - Veruno (NO)

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421876     History of Changes
Other Study ID Numbers: 60
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 2007

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