Early Detection of CTEPH in Patients After APE

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years

Signed consent to participate in the project and GDPR

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

ECHO evidence of severe PH at diagnosis of PE (PASP >60 mmHg)

Disqualifiers

Not agreeing to participate in the project

Contraindications to treatment

Trial population

Pacients matching all inclusion \& exclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standardized CTEPH Screening Protocol

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: CTEPH Screening Arm1 intervention

Trial outcomes

Primary outcomes

1

Positive predictive value of initial examination

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.

Time frame
Up to six months from enrollment
2

CTEPH detection rates

Results will be collected from study enrollment to evaluation of all completed examinations by a cardiologist at the specialized centre.

Time frame
Up to six months from enrollment
3

Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre

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.

Time frame
Up to six months from enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

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