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NCT Number: NCT06865326

Early Detection of CTEPH in Patients After APE

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital, Brno, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Positive predictive value of initial examination

    Time frame: Up to six months from enrollment

    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.

  2. CTEPH detection rates

    Time frame: Up to six months from enrollment

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

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

    Time frame: Up to six months from enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kateřina Ondrášková, Msc

CONTACT

[email protected]

604603143

Lucie Mandelová, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • General University Hospital, Prague

Registry information

Official study title

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

Acronym: CTEPH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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