Early Detection of CTEPH in Patients After APE
Recruiting · NCT06865326 · Observational (researchers observe without assigning treatment) · Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
View the official record on ClinicalTrials.gov →Interventions studied
Standardized CTEPH Screening Protocol
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- Not agreeing to participate in the project
- Contraindications to treatment
Where it is running
10 locations listed.
- Brno University Hospital - Brno, Czechia
- Havlíčkův Brod Hospital - Havlíčkův Brod, Czechia
- University Hospital Hradec Králové - Hradec Králové, Czechia
- Jihlava Hospital - Jihlava, Czechia
- Náchod Hospital - Náchod, Czechia
- University Hospital Olomouc - Olomouc, Czechia
- University Hospital Ostrava - Ostrava, Czechia
- Pardubice Hospital - Pardubice, Czechia
- Rychnov nad Kněžnou Hospital - Rychnov nad Kněžnou, Czechia
- Tábor Hospital - Tábor, Czechia