In the ten years since their beginning, the GISSI studies have obtained wide
recognition in the international world of cardiology and are considered a
methodological landmark.
Besides their results on the efficacy of the experimental treatments, these
studies have contributed knowledge on different aspects:
- Methodological and scientific aspects:
the GISSI studies, characterized by the wide participation of Italian Coronary
Care Units (about 4/5 of those existing in the country) and by the adoption
of protocols closely following clinical practice, have allowed the recruitment
of large numbers of patients over short periods of time, ensuring not only
a high statistical power but also the evaluation of the treatments' effects
in real populations of patients with acute myocardial infarction, avoiding
the artificial conditions of patient selection commonly shared by usual clinical
experimentations. The creation of a permanent network of clinical monitors
within Centres allowed to ensure a reliable and correct process of data
collection.
- Reliable data on the epidemiology of relevant clinical events:
the availability of a very large database has not only allowed an evaluation
of the incidence of the main clinical events which characterize the acute
phase of AMI, such as mortality, but also to estimate time trends of clinically
relevant events, in terms of incidence and prognosis (i.e.: ventricular
fibrillation, reinfarction, stroke, etc.)
- Transfer of the results to clinical practice:
in general, transfer of the results of the scientific literature to clinical
practice takes place very slowly. GISSI has accelerated this process: currently,
the use of thrombolysis in patients with acute myocardial infarction is
widespread (GISSI-3 data) and surely more common than that observed in CCUs
in the USA and in Canada.
- Feasibility of quality control programs of instrumental and laboratory
tests at national level:
in order to allow stratification of the risks of patients with myocardial
infarction after hospital discharge, several instrumental tests (bidimensional
echocardiography, holter, stress test) were collected. The centralised reading
of a 10% random sample of such tests has shown a reasonable degree of accordance
with the readings carried out locally. In GISSI Prevention quality control
of laboratory tests is planned.
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