December 1, 2005European Journal of Cardiovascular Prevention & Rehabilitation
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
Why the study?
Does a long-lasting multifactorial continued educational and behavioural programme reduce morbidity and mortality in patients with recent myocardial infarction who have completed initial cardiac rehabilitation?
Population
3,241 patients with recent myocardial infarction who completed an initial cardiac rehabilitation programme
Comparison
Long-lasting multifactorial continued… vs Usual care
Design
RCT, randomized
Follow-up
over 3 years
Authors
Discussion
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Member takes
Implication
Tests long-term intensive prevention post-MI; extends short-term rehabilitation evidence to sustained programs.
Key Points
- The GOSPEL trial outlines the rationale and design for assessing whether a long-lasting, multifactorial educational and behavioural intervention reduces morbidity and mortality after myocardial infarction compared to usual care.
- Multicentre, randomized, controlled study conducted across 78 cardiac rehabilitation centres in Italy.
- A total of 3,241 patients with recent myocardial infarction (<3 months) who completed initial rehabilitation were randomized to an intensive 3-year educational and behavioural intervention or usual care.
- The intensive arm received monthly sessions for 6 months, then sessions every 6 months for 3 years, incorporating aerobic exercise, lifestyle counselling, and clinical assessments; the primary endpoint evaluated combined morbidity and mortality.
- A total of 3,241 patients were successfully enrolled between January 2001 and December 2002 across participating Italian centres.
- Study outcome data and primary endpoint results regarding morbidity and mortality were scheduled for analysis and availability in mid-2006.
Structured PICO
Does a long-lasting multifactorial continued educational and behavioural programme reduce morbidity and mortality in patients with recent myocardial infarction who have completed initial cardiac rehabilitation?
P
Population
3,241 patients with recent (<3 months) myocardial infarction who completed an initial cardiac rehabilitation programme
I
Intervention
Long-lasting (over 3 years) multifactorial continued educational and behavioural programme (intensive approach) including aerobic exercise, comprehensive lifestyle and risk factor counselling, and clinical assessment (monthly from months 1 to 6, then every 6 months for 3 years)
C
Comparator
Usual care (returned to family physicians' care, attended reference centre only for 6-month and annual scheduled assessment)
O
Outcome
Morbidity and mortalitycomposite
The GOSPEL trial was designed to test whether a long-term, intensive secondary prevention program improves morbidity and mortality after myocardial infarction compared to usual care.
Cite This Study
Giannuzzi et al. (2005) studied this question.