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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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Pacients matching all inclusion & exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kateřina Ondrášková, Msc | Contact | 604603143 | katerina.ondraskova@uzis.cz | |
| Lucie Mandelová, PhD | Contact | lucie.mandelova@uzis.cz |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Jansa, prof. | General University Hospital of Prague | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno University Hospital | Recruiting | Brno | Czechia |
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| Havlíčkův Brod Hospital | Recruiting | Havlíčkův Brod | Czechia |
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| University Hospital Hradec Králové | Recruiting | Hradec Králové | Czechia |
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| Jihlava Hospital | Recruiting | Jihlava | Czechia |
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| Náchod Hospital | Recruiting | Náchod | Czechia |
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| University Hospital Olomouc | Recruiting | Olomouc | Czechia |
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| University Hospital Ostrava | Recruiting | Ostrava | Czechia |
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| Pardubice Hospital | Recruiting | Pardubice | Czechia |
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| Rychnov nad Kněžnou Hospital | Recruiting | Rychnov nad Kněžnou | Czechia |
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| Tábor Hospital | Recruiting | Tábor | Czechia |
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