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Novel Dynamic Imaging Technology for Diagnosing Pulmonary Hypertension

Application of Dynamic Digital Radiography in Diagnosis of Chronic Thromboembolic Pulmonary Hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096332
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-01-22
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Chronic thromboembolic pulmonary hypertension

Interventions

Gold Standard:The current diagnostic algorithm typically includes an initial assessment, hemodynamic assessment, and imaging tests. The initial evaluation includes a detailed examination of the patien
Index test:Based on DDR, the optimal cutoff value of pulmonary blood flow signal for the diagnosis of CTEPH was established, and a method for analyzing the amount of lung blood flow perfusion was esta

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years 2. Patients with confirmed or suspected CTEPH: a. Confirmed CTEPH: meets the diagnostic criteria for CTEPH recommended by the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines: • Adequate, regular anticoagulation therapy >=3 months • Radiographic evidence (including: pulmonary ventilation/perfusion imaging, transcatheter pulmonary angiography, CT pulmonary angiography) confirming the presence of pulmonary artery thromboembolism • Haemodynamics consistent with diagnostic criteria for pulmonary hypertension (i.e., mean pulmonary arterial pressure (mPAP) of >=25 mmHg at rest, at sea level, right heart catheterization, and pulmonary movement Pulmonary arterial wedge pressure (PAWP) =20 mmHg, or pulmonary artery systolic blood pressure estimated by cardiac ultrasound >35 mmHg • Has a history of lower extremity deep vein thrombosis or pulmonary embolism, or at least one of the following risk factors Heart rate>=100 beats per minute Oxygen saturation < 95% Swelling of the lower extremities Taking drugs that cause blood clotting disorders (such as glucocorticoids, birth control pills, etc.) Hypercoagulable state (e.g., thrombophilia, malignancy, nephrotic syndrome, postoperative, traumatic, etc.) 3. Agree and be able to complete functional dynamic digital radiography (DDR), right heart catheterization, and transcatheter pulmonary angiography 4. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients who have not signed the informed consent form; 2. Patients with severe renal insufficiency (eGFR<30 mL/min/1.73m^2); 3. Patients who are allergic to iodine contrast medium or have a history of severe allergic reaction; 4. Combined with other serious lung diseases that may significantly affect the assessment of pulmonary blood flow, including but not limited to: severe interstitial lung disease, advanced emphysema, history of lung surgery (such as lobectomy); 5. Other diseases that cause pulmonary artery stenosis, including but not limited to: congenital pulmonary artery stenosis, Takayasu Takayasu arteritis involving pulmonary arteries, pulmonary artery sarcoma, fibromediastinitis; 6. Pregnant or lactating women; 7. Patients with expected survival of less than 6 months.

Design outcomes

Primary

MeasureTime frame
DDR signal intensity ratio;

Countries

China

Contacts

Public ContactShen Jianzhong;Wang Yun

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

shenjz9@hotmail.com+86 13910226219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026