Early Non-invasive Detection of CTEPH After Pulmonary Embolism

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT02555137
• Date of registration: 15/09/2015
• Prospective Registration: Yes
• Primary sponsor: Leiden University
• Public title: Early Non-invasive Detection of CTEPH After Pulmonary Embolism InShape2
• Scientific title: Early Non-invasive Detection of CTEPH After Pulmonary Embolism - The InShape-2 Study
• Date of first enrolment: February 1, 2016
• Target sample size: 424
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555137
• Study type: Observational [Patient Registry]

Countries of recruitment

Belgium, Netherlands, Poland

Contacts

• Name: F.A. Klok, MD PhD
• Affiliation: Department of Thrombosis and Hemostasis LUMC Leiden

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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;

- Signed and dated informed consent of the subject available before the start of any
specific study procedures;

- Age =18 years;

Exclusion criteria:

- Known CTEPH or PH;

- Known (i.e. echocardiographic confirmed) NYHA class III or IV chronic heart failure
due to left ventricular systolic dysfunction, left ventricular diastolic dysfunction
or significant valvular lesions;

- Severe renal failure (eGFR <15 ml/min) or renal replacement therapy;

- 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;

- Non-compliance or inability to adhere to treatment or to the follow-up visits.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Other: 'prediction score' and 'rule-out criteria'

Primary Outcome(s)

The accuracy of the screening algorithm to detect CTEPH, as reflected by the 2-year incidence of confirmed CTEPH in patients in whom CTEPH was initially considered not present based on the 'risk stratification score' and the 'rule out criteria'. [Time Frame: 2-year follow-up]

Secondary Outcome(s)

3 Cost-effectiveness of the screening algorithm: a study-based cost-effectiveness analysis (CEA: diagnostic costs per early CTEPH diagnosis) and a model-based cost-utility analysis (CUA: societal costs per QALY). [Time Frame: 2-year follow-up]

Feasibility of the screening algorithm, the number of necessary echocardiograms at baseline and the number of relevant echocardiographic findings at baseline, i.e. those that require treatment [Time Frame: 2-year follow-up]

The cumulative incidence and incidence rate of CTEPH in the total study population with corresponding 95% confidence interval [Time Frame: 2-year follow-up]

incremental diagnostic accuracy of electrocardiographically derived ECG-vectoranalysis on top of the manual ECG assessment by comparing the c-statistics and reclassification numbers between the manually and automatically assessed ECG parameters [Time Frame: 2-year follow-up]

Inter-observer variability in the measurement of the RV/LV ratio on computed tomography pulmonary angiography (CTPA) expressed as the kappa-value of the ventricular dimension measurements by two independent researchers. [Time Frame: 2-year follow-up]

Secondary ID(s)

NL54450.058.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors