Early Detection of CTEPH in Patients After APE (CTEPH)

November 18, 2025 updated by: Institute of Health Information and Statistics of the Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
      • Havlíčkův Brod, Czechia
        • Recruiting
        • Havlíčkův Brod Hospital
        • Contact:
      • Hradec Králové, Czechia
      • Jihlava, Czechia
        • Recruiting
        • Jihlava Hospital
        • Contact:
      • Náchod, Czechia
      • Olomouc, Czechia
        • Recruiting
        • University Hospital Olomouc
        • Contact:
      • Ostrava, Czechia
        • Recruiting
        • University Hospital Ostrava
        • Contact:
      • Pardubice, Czechia
        • Recruiting
        • Pardubice Hospital
        • Contact:
      • Rychnov nad Kněžnou, Czechia
      • Tábor, Czechia
        • Recruiting
        • Tábor Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pacients matching all inclusion & exclusion criteria

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to six months from enrollment
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.
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
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.
Up to six months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

General University Hospital, Prague

Investigators

  • Study Director: Pavel Jansa, prof., General University Hospital of Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZIS 2024/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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