Clinical trial NCT06865326: Early Detection of CTEPH in Patients After APE
Official title: Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pulmonary Thromboembolism
Keywords: CTEPH
APE
Early detection
Czech Republic
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: General University Hospital, Prague
First posted: 2025-03-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The project is a national, prospective, multicenter, interventional 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, interventional 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

Eligibility criteria: 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 outcomes:
measure: Positive predictive value of initial examination
timeFrame: Up to six months from enrollment
measure: CTEPH detection rates
timeFrame: Up to six months from enrollment
measure: Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre
timeFrame: Up to six months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: General University Hospital of Prague
name: Pavel Jansa, prof.
role: STUDY_DIRECTOR
References: