Chronic Pulmonary Thromboembolism
Conditions
Keywords
CTEPH, APE, Early detection, Czech Republic
Brief 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.
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
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.
Sponsors
General University Hospital, Prague
Institute of Health Information and Statistics of the Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value of initial examination | 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. |
| CTEPH detection rates | 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. |
| Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre | 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. |
Countries
Czechia
Contacts
Primary ContactKateřina Ondrášková, Msc
Backup ContactLucie Mandelová, PhD
Outcome results
None listed