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Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance.
Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine.
Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension
This single-center, prospective diagnostic study is designed to investigate whether EIT-derived measures correlate with invasive hemodynamic parameters obtained by RHC. Adult patients referred for RHC due to suspected PAH or for disease staging will undergo standard catheterization, followed by short-term EIT monitoring. Some patients will additionally receive a hypertonic saline injection during a respiratory pause to enhance the perfusion signal. All EIT data will be processed offline using dedicated algorithms to separate ventilation and perfusion signals and to extract pulsatility-related parameters (e.g., amplitude, area, inflection points). These values will then be compared with RHC-derived hemodynamic measures such as mean pulmonary artery pressure (mPAP), pulmonary vascular resistance (PVR), cardiac output (CO), and stroke volume (SV).
The primary outcome of this study is to determine the diagnostic accuracy of EIT for detecting pulmonary hypertension, aiming at high sensitivity and clinical utility as a screening tool prior to invasive catheterization. Secondary analyses will include exploration of additional EIT-derived perfusion and pulsatility indices, assessment of diagnostic thresholds for different levels of PAH severity, and evaluation of prognostic implications.
Risks associated with participation are minimal, as EIT is non-invasive and safe. The risks of RHC are those inherent to the procedure and are independent of the study. While no direct benefit is expected for individual participants, the findings may provide important insights into the use of EIT as a less invasive diagnostic strategy for PAH, with potential implications for clinical practice and patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Arm | Experimental | Patients with suspected or confirmed pulmonary arterial hypertension (PAH) undergoing right heart catheterization will also be monitored with electrical impedance tomography (EIT) around the time of the procedure. EIT-derived signals will be compared with invasive hemodynamic measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Impedance Tomography (EIT) | Diagnostic Test | Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure | Sensitivity (%) of EIT-derived pulsatility amplitude (measured in arbitrary impedance units, ΔZ) to detect pulmonary hypertension defined as mean pulmonary artery pressure (mPAP ≥20 mmHg) measured in mmHg by Right Heart Catheterization (RHC). Diagnostic performance will be assessed using Receiver Operating Characteristic (ROC) curve analysis and area under the curve (AUC). | At the time of right heart catheterization (baseline, single assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pearson or Spearman Correlation Coefficient (r) Between EIT-Derived Pulsatility Amplitude (ΔZ) and Mean Pulmonary Artery Pressure (mmHg) | Correlation coefficient (r) between EIT-derived pulsatility amplitude (ΔZ, arbitrary impedance units) and mean pulmonary artery pressure (mmHg), pulmonary vascular resistance (Wood units), cardiac output (L/min), and stroke volume (mL), all measured invasively by Right Heart Catheterization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo BP Amato, MD PhD | Contact | +55113061-7361 | marcelo.amato@hc.fm.usp.br | |
| Jade Lara de Melo, PT | Contact | +5534992911757 | jade.l.melo.l@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19491438 | Background | Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2. | |
| 11540235 |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| Right Heart Catheterization | Procedure | Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures. |
|
| At the time of right heart catheterization |
| Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%) | Correlation between EIT-derived pulsatility amplitude (ΔZ) and Fractional Area Change (%, measured in millimeters by transthoracic echocardiography). | Immediately after right heart catheterization (single assessment at baseline) |
| Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm) | Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (TAPSE, measured in millimeters by transthoracic echocardiography). | Immediately after right heart catheterization (single assessment at baseline) |
| Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s) | Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tissue Doppler Systolic Velocity (cm/s). (S', measured in millimeters by transthoracic echocardiography). | immediately after right heart catheterization |
| Sensitivity (%), Specificity (%), and Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Detection of Pulmonary Hypertension at Different mPAP Thresholds | Diagnostic performance of EIT-derived pulsatility amplitude (ΔZ) to detect pulmonary hypertension defined by mean pulmonary artery pressure thresholds of ≥20 mmHg and ≥40 mmHg measured by Right Heart Catheterization. | At the time of Right Heart Catheterization. |
| Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Classification of Pulmonary Hypertension Severity | Ability of EIT-derived pulsatility amplitude (ΔZ) to classify pulmonary hypertension severity categories defined by mean pulmonary artery pressure ranges (20-40 mmHg vs >40 mmHg), measured invasively by Right Heart Catheterization. | At the time of right heart catheterization |
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| 3568566 | Background | Eyuboglu BM, Brown BH, Barber DC, Seagar AD. Localisation of cardiac related impedance changes in the thorax. Clin Phys Physiol Meas. 1987;8 Suppl A:167-73. doi: 10.1088/0143-0815/8/4a/021. |
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| 31504429 | Background | Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available. |
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| 21969018 | Background | Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3. |
| 14693669 | Background | Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23. |
| 10847195 | Background | Vonk-Noordegraaf A 2nd, Janse A, Marcus JT, Bronzwaer JG, Postmust PE, Faes TJ, De Vries PM. Determination of stroke volume by means of electrical impedance tomography. Physiol Meas. 2000 May;21(2):285-93. doi: 10.1088/0967-3334/21/2/308. |
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| 22240409 | Background | Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11. |
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| D002318 |
| Cardiovascular Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |