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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 23, 2014