Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-03-07
2026-12-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindications to treatment
18 Years
ALL
No
Sponsors
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General University Hospital, Prague
OTHER
Institute of Health Information and Statistics of the Czech Republic
OTHER_GOV
Responsible Party
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Principal Investigators
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Pavel Jansa, prof.
Role: STUDY_DIRECTOR
General University Hospital of Prague
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UZIS 2024/2
Identifier Type: -
Identifier Source: org_study_id
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