Pulmonary Embolism Clinical Trial
Official title:
Institutional Registry of Thromboembolic Disease
The purpose of this study is to create an institutional registry of Thromboembolic disease
through a prospective survey based on epidemiological data, risk factors, diagnosis,
prognosis, treatment, monitoring and survival.
The main goal is to describe the occurrence of thromboembolic disease and the characteristics
of clinical presentation, evolution and predisposing factors of these episodes in the
population of the Hospital Italiano de Buenos Aires.
Deep Vein Thrombosis (DVT) and pulmonary thromboembolism (PTE) are the most common clinical
manifestations of thromboembolic disease (TD). The PTE is one of the most important
preventable causes of death in hospitalized patients, with a mortality up to 17% in a 3 month
period. During the past 20 years important changes have been made in terms of clinical
awareness, diagnostic tools and treatment.
No data has been found in our country which shows the TD population incidence. According to
WHO, the sex-specific mortality rate associated to TD in Argentina in the year 2001
(including DVT and PE coded by ICD10), estimated by epidemiological death records was 0.2 /
100,000 for men and 0, 5 / 100000 for women (based on 37 and 87 cases respectively). This
seems to represent a clear report deficiency.
Registries are systematic surveys which are found in a database. They function as monitoring
lists and allow epidemiological evaluations of the affected patients. Several methods can be
found to diagnose thromboembolic disease. These include OPTIMEV: Interrogatoire Optimisation
de l'évaluation du risque dans l'Maladie ThromboEmbolique of Veineuse (its aim is to include
about 10000 cases of suspected DT); MAPPET: Management Strategy and Prognosis of Pulmonary
Embolism Registry (its goal is to include 1001 consecutive patients with PE), ICOPER:
International Cooperative Pulmonary Embolism Registry (to include 2454 consecutive patients
with PE), DVT FREE (including TVP 5451),RIETE: Computerized Patient Record venous
thromboembolism in Spain (to register patients with DVT or PE).
No published records have been found regarding the approach used for diagnosis and treatment
of suspected PTE patients in our country. Moreover, no publications on systematic
epidemiological data (risk factors, assessment and follow-up survival, complications and
recurrences)were found.
The registry of suspected TD cases will allow us to distinguish the disease characteristics
in our community, the most used diagnostic strategies, the results and the pathology
evolution in time.
The Hospital Italiano counts with computerized clinical records which provide incidence,
morbidity and mortality data.
It is our belief that this registry will allow us to design studies to improve and
standardize the most used diagnostic strategies.
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