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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00005939
• Date of registration: 03/07/2014
• Prospective Registration: Yes
• Primary sponsor: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Public title: Follow-Up after Acute Pulmonary Embolism - a Prospective Observational Multicenter Cohort Study
• Scientific title: Follow-Up after Acute Pulmonary Embolism - a Prospective Observational Multicenter Cohort Study - FOCUS
• Date of first enrolment: 29/09/2014
• Target sample size: 1000
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00005939
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis

Countries of recruitment

Germany

Contacts

• Name: Stavros Konstantinides
• Affiliation: Centrum für Thrombose und Hämostase,Universitätsmedizin der Johannes Gutenberg-Universität Mainz

• Name: Stavros Konstantinides
• Affiliation: Centrum für Thrombose und HämostaseUniversitätsmedizin der Johannes Gutenberg-Universität Mainz

Key inclusion & exclusion 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: 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.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary embolism without mention of acute cor pulmonale

I26.9

I26.9

Intervention(s)

Group 1: Patients with confirmed acute pulmonary embolism will be treated according to current guidleines and invited to control vists in the clinic after 3, 12 and 24 months where data, including the results of a 6-minutes walking test and cardiopulmonary exercise testing will be recorded and 2 QoL questionnaires will be administered to the patients.

Primary Outcome(s)

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 Outcome(s)

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

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Berlin

Bayer Vital GmbH

Ethics review

Status: Approved
Approval date: 10/06/2014
Contact:

[e-mail]

Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz

[phone]

[e-mail]

Results

• Date Completed: 08/09/2020
• URL: http://drks.de/search/en/trial/DRKS00005939#studyResults