CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 700 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01781858
NCT01781858N/ACompleted

Study on the Clinical Course Of Pulmonary Embolism

University of Padova·observational·Posted Feb 1, 2013·Updated Jun 14, 2016

In Brief

An observational study for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 700 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2013
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.4 years ago