Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism

Status: Recruiting
Intervention Type: Other
Study Type: Observational
SUMMARY

The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age over 18 years

• Signed consent to participate in the project and GDPR

• Patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy:

‣ Patients with new-onset and ongoing or progressive dyspnea (min. NYHA II) after a pulmonary embolism episode or worsening of dyspnea after a pulmonary embolism episode compared to the status before the episode (at least 1 HYHA grade) or

⁃ Asymptomatic patients after a pulmonary embolism episode and at least one of the following risk factors:

• ECHO evidence of severe PH at diagnosis of PE (PASP \>60 mmHg)

• Antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein I (B2GPI) antibodies + anticardiolipin)

• Infected permanent venous inlets and cardiac pacing/defibrillation intravascular systems

• Presence of ventriculoatrial shunt for treatment of hydrocephalus

• Nonspecific intestinal inflammation (ulcerative colitis, Crohn's disease)

• History of splenectomy

• Myeloproliferative disorders

• Chronic osteomyelitis

Contact Information
Primary
Kateřina Ondrášková, Msc
katerina.ondraskova@uzis.cz
604603143
Backup
Lucie Mandelová, PhD
lucie.mandelova@uzis.cz
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 500
Treatments
CTEPH Screening Arm
Patients after APE matching all inclusion \& exclusion criteria will undergo a standardized screening process for early detection of CTEPH. The process will include the new screening protocol and in case of a risk of CTEPH, transfer to specialized center for further management.
Sponsors
Collaborators: General University Hospital, Prague
Leads: Institute of Health Information and Statistics of the Czech Republic

This content was sourced from clinicaltrials.gov