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Recruiting NCT06865326

Early Detection of CTEPH in Patients After APE

— Observational Chronic Pulmonary Thromboembolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standardized CTEPH Screening Protocol.
Who it may be relevant to
Registry conditions: Chronic Pulmonary Thromboembolism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism

Overview

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

  • Other 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.

Primary outcome measures

  • Positive predictive value of initial examination [Time frame: Up to six months from enrollment]
  • CTEPH detection rates [Time frame: 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 [Time frame: Up to six months from enrollment]

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:
  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 10 centers
  • Brno University Hospital — Brno
  • Havlíčkův Brod Hospital — Havlíčkův Brod
  • University Hospital Hradec Králové — Hradec Králové
  • Jihlava Hospital — Jihlava
  • Náchod Hospital — Náchod
  • University Hospital Olomouc — Olomouc
  • University Hospital Ostrava — Ostrava
  • Pardubice Hospital — Pardubice
  • … and 2 more centers

Identifiers

NCT: NCT06865326 · UZIS 2024/2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗