Institutional Registry of Thromboembolic Disease (IRTD)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Thromboembolism Venous Thromboembolism Pulmonary Embolism |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Estimated Enrollment: | 1500 |
| Study Start Date: | August 2006 |
| Groups/Cohorts |
|---|
|
suspected thromboembolic disease
Patients with thromboembolic disease according to diagnostic tests (MDTC with angiography, scintigraphy V/Q, dimer d, ecographia doppler, etc ) requiered by the physician.
|
Detailed 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 included 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. What is more, 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.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The eligible population is all patients equal or older than 17 years, evaluated and followed in the Hospital Italiano de Buenos Aires, with an episode of pulmonary embolism suspected by the medical examiner or confirmed diagnosis of DVT or PE. The aim is to include the entire population that meets the criteria for inclusion and no exclusion.
Inclusion Criteria:
- Equal to or older than 17 years.
- Followed in HIBA.
- Suspected pulmonary embolism or diagnosed venous thrombosis
Exclusion Criteria:
- Pacient 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.
Contacts and Locations| Contact: Diego H Giunta, MD | 005411-49590200 ext 4419 | diego.giunta@hospitalitaliano.org.ar |
| Contact: Cristina M Elizondo, MD | 005411-49590200 ext 4419 | cristina.elizondo@hospitalitaliano.org.ar |
| Argentina | |
| Hospital Italiano | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Diego H Giunta, MD 005411-49590200 ext 4419 diego.giunta@hospitalitaliano.org.ar | |
| Contact: Cristina M Elizondo, MD 005411-49590200 ext 4419 cristina.elizondo@hospitalitaliano.org.ar | |
| Principal Investigator: Diego H Giunta, MD | |
| Principal Investigator: | Diego H Giunta, MD | Internal Medicine Clinical research Area Coordinator |
| Study Director: | Fernan Gonzales Bernaldo de Quirós, MD | Internal Medicine Clinical Research Area Chief |
| Study Chair: | Fernando Vazquez, MD | Internal Medicine Staff |
More Information
No publications provided
| Responsible Party: | Diego Giunta, Hospital Italiano de Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT01372514 History of Changes |
| Other Study ID Numbers: | 995 |
| Study First Received: | June 10, 2011 |
| Last Updated: | July 5, 2011 |
| Health Authority: | Argentina: Human Research Bioethics Committee |
Keywords provided by Hospital Italiano de Buenos Aires:
|
Thromboembolism Venous Thromboembolism Pulmonary Embolism |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 23, 2013