Early Detection of CTEPH in Patients After APE

NCT06865326 | Recruiting

• 1 other identifier: UZIS 2024/2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chronic Pulmonary Thromboembolism

Keywords

CTEPH; APE; Early detection; Czech Republic

Outcome Measures

Primary Outcomes (3)

• Positive predictive value of initial examination

  Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.

  Up to six months from enrollment

• CTEPH detection rates

  Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the specialized centre.

  Up to six months from enrollment

• Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre

  Examinations include echocardiography, CT scan or scintigraphy, and possibly other examinations determined by the cardiologist. Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the primary detection site.

  Up to six months from enrollment

Study Arms (1)

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.

Other: Standardized CTEPH Screening Protocol

Interventions

Standardized CTEPH Screening Protocol OTHER

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.

CTEPH Screening Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pacients matching all inclusion \& exclusion criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (10)

Brno University Hospital

Brno, Czechia

RECRUITING

Havlíčkův Brod Hospital

Havlíčkův Brod, Czechia

RECRUITING

University Hospital Hradec Králové

Hradec Králové, Czechia

RECRUITING

Jihlava Hospital

Jihlava, Czechia

RECRUITING

Náchod Hospital

Náchod, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Czechia

RECRUITING

Pardubice Hospital

Pardubice, Czechia

RECRUITING

Rychnov nad Kněžnou Hospital

Rychnov nad Kněžnou, Czechia

RECRUITING

Tábor Hospital

Tábor, Czechia

RECRUITING

Study Officials

• Pavel Jansa, prof.

  General University Hospital of Prague

  STUDY DIRECTOR

Central Study Contacts

Kateřina Ondrášková, Msc

CONTACT

604603143; katerina.ondraskova@uzis.cz

Lucie Mandelová, PhD

CONTACT

lucie.mandelova@uzis.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: March 7, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CZ (10)