Follow-Up after Acute Pulmonary Embolism - a Prospective Observational Multicenter Cohort Study

Completed

• Conditions: Pulmonary embolism without mention of acute cor pulmonale; I26.9

• Registration Number: DRKS00005939
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

In this prospective study, the cumulative 2-year incidence of chronic thrombo-embolic pulmonary hypertension (CTEPH) was 2.3%, but post-PE impairment (PPEI) diagnosed by standardized criteria was frequent 16%) and associated with CTEPH. Our findings thus support systematic follow-up of patients after acute PE and may help to optimize guideline recommendations and algorithms for post-PE care.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-03
• Study Completion: 2020-09-08
• Results First Posted: 2022-04-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1096

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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; <br>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 Outcome Measures

Name	Time	Method
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