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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (10)
Facility
City
Region
Status
Brno University Hospital
Brno
Czechia
Recruiting
Havlíčkův Brod Hospital
Havlíčkův Brod
Czechia
Recruiting
University Hospital Hradec Králové
Hradec Králové
Czechia
Recruiting
Jihlava Hospital
Jihlava
Czechia
Recruiting
Náchod Hospital
Náchod
Czechia
Recruiting
University Hospital Olomouc
Olomouc
Czechia
Recruiting
University Hospital Ostrava
Ostrava
Czechia
Recruiting
Pardubice Hospital
Pardubice
Czechia
Recruiting
Rychnov nad Kněžnou Hospital
Rychnov nad Kněžnou
Czechia
Recruiting
Tábor Hospital
Tábor
Czechia
Recruiting
More Institute of Health Information and Statistics of the Czech Republic trials in Czechia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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