Chronic Thromboembolic Pulmonary Hypertension CTEPH
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age >=18 years at the time of consent. 2) High echocardiographic probability of PH according to major guidance (Japanese and European guidelines) 2,9, and scheduled to undergo lung V/Q scintigraphy and RHC for definitive diagnosis of CTEPH versus non-CTEPH. 3) Ability to understand the study information and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1) Severe obstructive lung disease (FEV1 100 beats per minute). 4) Acute symptomatic pulmonary embolism on imaging within 3 months prior to enrolment. 5) Congenital or acquired abnormalities of pulmonary vascular anatomy. 6) History of lung resection or chest radiotherapy. 7) Active thoracic malignancy. 8) History of vasculitis. 9) Presence of devices in the chest (such as pacemakers or implantable cardioverter-defibrillators) in which pulsed X-ray exposure is contraindicated because of potential device malfunction. 10) Pregnant women. 11) Any other condition judged by the investigator to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy for initial discrimination between CTEPH and non-CTEPH, comparing standard work-up plus DCR versus standard work-up alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Sensitivity, specificity, positive predictive value and negative predictive value for CTEPH versus non-CTEPH discrimination for each diagnostic strategy (ITT set). 2) STARD-based performance metrics (including accuracy and area under the receiver operating characteristic curve) for DCR using V/Q scintigraphy as the reference standard (full-analysis set). 3) Agreement (kappa coefficient) between DCR-based analysis and V/Q scintigraphy regarding the presence of regional perfusion defects in each of six lung regions (full-analysis set). | — |
Contacts
Center for Clinical and Translational Research, Kyushu University Hospital