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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00005939
Enrollment
1000
Registered
2014-07-03
Start date
2014-09-29
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I26.9

Interventions

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

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactStavros Konstantinides

Centrum für Thrombose und HämostaseUniversitätsmedizin der Johannes Gutenberg-Universität Mainz

sabrina.rump@unimedizin-mainz.de06131 17 8382

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026