Institutional Registry of Thromboembolic Disease

Pulmonary Embolism Clinical Trial

— IRTD  

Official title:

Institutional Registry of Thromboembolic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01372514
• Other study ID #: 995
• Status: Recruiting
• Start date: August 2006
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: Hospital Italiano de Buenos Aires
• Contact: Diego H Giunta, MD
• Phone: 005411-49590200
• Email: diego.giunta[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Equal to or older than 17 years.

• Followed in HIBA.

• Suspected pulmonary embolism or diagnosed venous thrombosis

Exclusion Criteria:

• Patient with monitoring and care at another facility who only attend the hospital to use its diagnostic method.

• Patient's refusal to participate in the registry or informed consent process.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence		4 years
Secondary	evaluate new hypothesis		yearly