Institutional Registry of Thromboembolic Disease (IRTD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2006 by Hospital Italiano de Buenos Aires
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01372514
First received: June 10, 2011
Last updated: April 1, 2014
Last verified: July 2006
  Purpose

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.


Condition
Thromboembolism
Venous Thromboembolism
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Institutional Registry of Thromboembolic Disease

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • Incidence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • incidence [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate new hypothesis [ Time Frame: yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 4500
Study Start Date: August 2006
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
suspected thromboembolic disease
Patients with thromboembolic disease according to diagnostic tests (MDTC with angiography, scintigraphy V/Q, dimer d, ecografia doppler, etc. ) required 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 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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372514

Contacts
Contact: Diego H Giunta, MD 005411-49590200 ext 4419 diego.giunta@hospitalitaliano.org.ar
Contact: Lourdes M Posadas-Martínez, MD 005411-49590200 ext 4419 maria.posadas@hospitalitaliano.org.ar

Locations
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         
Sub-Investigator: Lourdes Posadas-MArtinez, MD         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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
Study Chair: Lourdes Posadas-MArtínez, MD Internal Medicine Clinical research Area , HIBA
  More Information

No publications provided by Hospital Italiano de Buenos Aires

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Diego Hernan Giunta, MD, MD, 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: April 1, 2014
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 July 20, 2014