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Study on the Clinical Course Of Pulmonary Embolism

NCT01781858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2016-06-14

No results posted yet for this study

Summary

The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.

Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient.

Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims:

1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;
2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE;
3. to evaluate whether a relation exists between chronic residual PE and CTEPH
4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;
5. to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH;
6. to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences.

For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.

Conditions

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Raffaele Pesavento, MD · University of Padova

  • Paolo Prandoni, MD,PHD · University of Padova

  • Antonio Pagnan, MD · University of Padova

  • Gualtiero Palareti, MD · University of Bologna

  • Antonio Palla, MD · University of Pisa

  • Vittorio Pengo, MD · University of Padova

  • Franco Piovella, MD · University of Pavia - Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-05-31
Completion
2014-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781858 on ClinicalTrials.gov