CClinicalTrials.gg
RecruitingNCT06865326CTEPHUpdated Nov 21, 2025

Early Detection of CTEPH in Patients After APE

An observational study in Chronic Pulmonary Thromboembolism, sponsored by Institute of Health Information and Statistics of the Czech Republic. Recruiting at 10 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Institute of Health Information and Statistics of the Czech Republic · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic.

The global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with CTEPH and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. The timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death.

The main objective of this activity is to validate the CTEPH screening process, which will benefit 500 patients in approximately 10 selected centres. Subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. The process will include a review and evaluation of the screening algorithm in patients in the pilot.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002007

02

Conditions studied

  • Chronic Pulmonary Thromboembolism

Keywords

  • CTEPH
  • APE
  • Early detection
  • Czech Republic
03

In context

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic is the lead sponsor of 14 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pacients matching all inclusion \& exclusion criteria

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:

    1. 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
    2. 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

Exclusion Criteria:

  • Not agreeing to participate in the project
  • Contraindications to treatment
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to six months from enrollment

  2. CTEPH detection rates

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

    Time frame: Up to six months from enrollment

  3. 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.

    Time frame: Up to six months from enrollment

07

Study locations

10 of 10 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06865326
Lead sponsor
Institute of Health Information and Statistics of the Czech Republic
Collaborators
General University Hospital, Prague
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
Mar 7, 2025
Primary completion
May 31, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 21, 2025

Study contacts

Kateřina Ondrášková, Msc
Contact
katerina.ondraskova@uzis.cz
604603143
Lucie Mandelová, PhD
Contact
lucie.mandelova@uzis.cz
Pavel Jansa, prof.
study director · General University Hospital of Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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