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Facilitating Diagnosis of CTEPH With Dynamic Chest Radiography: An Investigator-led, Multicenter, Assessor-blinded, Case-wise Randomized, Superiority Reader Study in Patients With Echocardiographically Suspected Pulmonary Hypertension

Facilitating Diagnosis of CTEPH With Dynamic Chest Radiography: An Investigator-led, Multicenter, Assessor-blinded, Case-wise Randomized, Superiority Reader Study in Patients With Echocardiographically Suspected Pulmonary Hypertension, Comparing Standard Initial Workup (Blood Test, Chest X-ray, ECG, Pulmonary Function Test) Plus A DCR-based Pulmonary Circulation Analysis Program with Standard Initial Workup alone for Early Diagnosis of Chronic Thromboembolic Pulmonary Hypertension - FIND-DCR Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2072250027
Enrollment
108
Registered
2025-05-26
Start date
2025-07-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Interventions

Addition of dynamic chest X-ray
Mass Chest X-Ray

Sponsors

Abe Kohtaro
Lead Sponsor
Hosokawa Kazuya
Collaborator

Eligibility

Sex/Gender
All

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

MeasureTime frame
Diagnostic accuracy for initial discrimination between CTEPH and non-CTEPH, comparing standard work-up plus DCR versus standard work-up alone.

Secondary

MeasureTime 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

Public ContactTomomi Nagayama

Center for Clinical and Translational Research, Kyushu University Hospital

nagayama.tomomi.325@m.kyushu-u.ac.jp+81-92-642-6290

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026