- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01372514
Institutional Registry of Thromboembolic Disease (IRTD)
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.
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Diego H Giunta, MD
- Phone Number: 4419 005411-49590200
- Email: diego.giunta@hospitalitaliano.org.ar
Study Contact Backup
- Name: Lourdes M Posadas-Martínez, MD
- Phone Number: 4419 005411-49590200
- Email: maria.posadas@hospitalitaliano.org.ar
Study Locations
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Buenos Aires, Argentina
- Recruiting
- Hospital Italiano
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Contact:
- Diego H Giunta, MD
- Phone Number: 4419 005411-49590200
- Email: diego.giunta@hospitalitaliano.org.ar
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Contact:
- Cristina M Elizondo, MD
- Phone Number: 4419 005411-49590200
- Email: cristina.elizondo@hospitalitaliano.org.ar
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Principal Investigator:
- Diego H Giunta, MD
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Sub-Investigator:
- Lourdes Posadas-MArtinez, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence
Time Frame: 4 years
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4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluate new hypothesis
Time Frame: yearly
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yearly
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Collaborators and Investigators
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
Publications and helpful links
General Publications
- Grande Ratti MF, Posadas-Martinez ML, Vicens J, Gonzalez Bernaldo de Quiros F, Vazquez FJ, Giunta DH. Incidence of hospital-acquired venous thromboembolic disease. Rev Fac Cien Med Univ Nac Cordoba. 2018 Jun 12;75(2):82-87. doi: 10.31053/1853.0605.v75.n2.17243.
- Vazquez FJ, Posadas-Martinez ML, de Quiros FG, Giunta DH. Prognosis of patients with suspected pulmonary embolism in Buenos Aires: a prospective cohort study. BMC Pulm Med. 2014 Dec 15;14:200. doi: 10.1186/1471-2466-14-200.
- Angriman F, Ferreyro BL, Posadas-Martinez ML, Giunta D, Vazquez FJ, Vollmer WM. Wells Score and Poor Outcomes Among Adult Patients With Subsegmental Pulmonary Embolism: A Cohort Study. Clin Appl Thromb Hemost. 2015 Sep;21(6):539-45. doi: 10.1177/1076029614559772. Epub 2014 Nov 25.
- Ferreyro BL, Angriman F, Giunta D, Posadas-Martinez ML, Vazquez F, De Quiros FG, Amaral AC, Scales DC. Predictive score for estimating cancer after venous thromboembolism: a cohort study. BMC Cancer. 2013 Jul 22;13:352. doi: 10.1186/1471-2407-13-352.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 995
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