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RecruitingNCT06865326

Early Detection of CTEPH in Patients After APE

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

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Enrollment

500 participants

Start Date

Mar 7, 2025

Study Type

OBSERVATIONAL

Conditions

Chronic Pulmonary Thromboembolism

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

Min Age: 18 Years

Inclusion Criteria13

  • 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 Criteria2

  • Not agreeing to participate in the project
  • Contraindications to treatment

Interventions

OTHERStandardized CTEPH Screening Protocol

Implementation of a standardized screening algorithm for early detection of CTEPH in patients after Acute Pulmonary Embolism (APE) and establishment of optimized referral of patients to specialized centers.

Locations(10)

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

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NCT06865326