I26.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Objectively confirmed diagnosis of acute symptomatic PE by multidetector computed tomography (CT), pulmonary angiography, or V/Q lung scan according to established diagnostic criteria (1), with or without symptomatic deep vein thrombosis; 2) Ability of subject to understand character and individual consequences of participation in the study; 3) Written informed consent must be available before enrollment in the study; 4) Age =18 years
Exclusion criteria
Exclusion criteria: 1) Subjects unwilling or unable to sign the informed consent form; 2) Patients in whom the diagnosis of PE is an asymptomatic incidental finding during diagnostic workup for another disease; 3) Patients with previously diagnosed chronic thromboembolic pulmonary hypertension; 4) No subject will be allowed to enroll in this study more than once.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Confirmed diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at any follow-up visit (at 3, 12 und 24 months) during 2 year-follow-up; 2) Post-PE impairment at =1 follow-up visit, defined by deterioration - compared to the previous visit or to the findings at discharge - by at least one category, or persistence of the greatest-severity category, in =1 of the echocardiographic parameters PLUS deterioration by at least one category or persistence of the greatest-severity category in =1 of the clinical, functional, or laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall mortality, recurrent deep vene thrombosis od pulmonal embolism, stroke, functional impairment defined by oxygen comsumption during exercise test, 6-minute walkingtest and Borg's dyspnoea Index, echcardiographic evidence of pulmonal hypertension, changes in quality of life at 3, 12 and 24 months | — |
Countries
Germany
Contacts
Centrum für Thrombose und HämostaseUniversitätsmedizin der Johannes Gutenberg-Universität Mainz