Early Detection of CTEPH in Patients After APE

Institute of Health Information and Statistics of the Czech Republic

Status: Enrolling

Conditions: Chronic Pulmonary Thromboembolism

Treatments: Other: Standardized CTEPH Screening Protocol

Study type: Observational

Funder types: Other

Identifiers

NCT06865326

UZIS 2024/2

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

CTEPH Screening Arm

Description:

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.

Treatment:

Other: Standardized CTEPH Screening Protocol