Early non-invasive detection of CTEPH after pulmonary embolism

Phase 4

Completed

Conditions: CTEPH
high blood pressure in pulmonary hypertension due to chronic thrombi
10019280
10037454
10014523

Registration Number: NL-OMON46977

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 239

Inclusion Criteria

1) All patients with an objectivated first or recurrent diagnosis of symptomatic acute PE, who have been treated for at least three months with therapeutically dosed anticoagulant therapy according to current guidelines;
2) Signed and dated informed consent of the subject available before the start of any specific study procedures;
3) Age *18 years;

Exclusion Criteria

1) Known CTEPH or PH;
2) 2) Known (i.e. echocardiographic confirmed) NYHA class III or IV chronic heart failure due to left ventricular systolic dysfunction with an EF <50%, left ventricular diastolic dysfunction of at least grade 2 or significant valvular lesions;
3) Severe renal failure (eGFR <15 ml/min) or renal replacement therapy;
4) Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent;
5) Non-compliance or inability to adhere to treatment or to the follow-up visits.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the accuracy of the screening algorithm to detect<br /><br>CTEPH, as reflected by the 2-year incidence of confirmed CTEPH in patients in<br /><br>whom CTEPH was initially ruled out without performing echocardiography.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Incidence of CTEPH<br /><br>2) Feasibility of the screening algorithm, i.e. number of necessary<br /><br>echocardiograms at baseline and the number of relevant echocardiographic<br /><br>findings at baseline, i.e. a finding that warrants therapeutic intervention;<br /><br>3) Cost-effectiveness of the screening algorithm;<br /><br>4) Additional diagnostic accuracy of electrocardiographically derived<br /><br>ECG-vector cardiogram (VCG) analysis on top of the manual ECG assessment;<br /><br>5) Determination of the inter-observer variability in the measurement of the<br /><br>RV/LV ratio on computed tomography pulmonary angiography (CTPA).<br /><br>6) Prevalence of the six radiological predictors of CTEPH (according to the<br /><br>InShape III study) and correlate this with the InShape II screening program.</p><br>