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Pulmonary ThromboendarterectomyNCT07577700

Assessment of Pulmonary Perfusion and Hemodynamic Measurements by Electrical Impedance Tomography in Patients Undergoing Pulmonary Thromboendarterectomy.

A study testing Electrical Impedance Tomography (EIT)., Pulmonary Perfusion SPECT-CT. and Pulmonary Thromboendarterectomy. in people with Pulmonary Thromboendarterectomy and Pulmonary Embolism and Thrombosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition in which old blood clots block the blood vessels in the lungs, making it harder for the heart to pump blood through the lungs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electrical Impedance Tomography (EIT)., Pulmonary Perfusion SPECT-CT. and Pulmonary Thromboendarterectomy.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBrazil
Study dates
25 Feb 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) followed at the Pulmonology Service of InCor-HCFMUSP and scheduled for pulmonary thromboendarterectomy at InCor-FMUSP.

Who cannot join

  • Age under 18 years
  • Pregnancy
  • Structural heart disease (atrial septal defect, ventricular septal defect, or valvular heart disease)
  • Cardiac arrhythmias
  • Use of a cardiac pacemaker or other implantable electronic device
  • Skin lesions on the thoracic region at the site of EIT electrode belt placement
Show all 10Show fewer
  • Absence of central venous access on the day of the preoperative protocol evaluation
  • Difficulty understanding the procedures to be performed
  • Refusal to participate in the study (non-signing of the Informed Consent Form)
  • Refusal by the attending medical team

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marcelo BP Amato, MD PhD contact

+55113061-7361

marcelo.amato@hc.fm.usp.br

Jaomar JC Salazar, MD contact

+5511966477244

jaomar@usp.br

Brazil1 site, 1 recruiting
  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-900

    Marcelo BP Amato, MD PhD, +55113061-7361, marcelo.amato@hc.fm.usp.br

    Jaomar JC Salazar, MD, +5511966477244, jaomar@usp.br

    Recruiting

Other trials in Brazil

About this study

Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition in which old blood clots block the blood vessels in the lungs, making it harder for the heart to pump blood through the lungs. Surgery called pulmonary thromboendarterectomy can remove these clots and improve blood flow, but doctors need reliable ways to evaluate lung blood flow before and after surgery.

This study will evaluate a bedside imaging method called electrical impedance tomography (EIT), which can measure how blood flows through different regions of the lungs without radiation or invasive procedures. Patients undergoing surgery for CTEPH will be monitored with EIT before and after surgery, and the results will be compared with standard lung perfusion imaging.

The goal of this study is to determine whether EIT can provide useful information about lung blood flow and changes after surgery, and whether it could serve as a complementary bedside tool to help monitor patients with CTEPH.

Read the detailed description

Chronic thromboembolic pulmonary hypertension (CTEPH) results from persistent obstruction of the pulmonary arteries by organized thromboembolic material and is a potentially curable cause of pulmonary hypertension. Pulmonary thromboendarterectomy is the treatment of choice for eligible patients and leads to significant improvement in pulmonary perfusion and hemodynamics.

Assessment of regional pulmonary perfusion is essential in the management of CTEPH. While perfusion SPECT/CT is commonly used for this purpose, it cannot be performed at the bedside and involves exposure to ionizing radiation. Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that allows bedside assessment of lung ventilation and pulmonary perfusion through analysis of pulsatility-related impedance changes.

In this prospective diagnostic study, pulmonary perfusion assessed by EIT will be evaluated in patients undergoing pulmonary thromboendarterectomy and compared with perfusion SPECT/CT. EIT measurements will be obtained in the perioperative period, and perfusion changes will be analyzed using quantitative indices derived from impedance signals. The study focuses on the feasibility and performance of EIT as a bedside method for assessing pulmonary perfusion changes associated with surgical treatment of CTEPH.

Being tested
Electrical Impedance Tomography (EIT)., Pulmonary Perfusion SPECT-CT., Pulmonary Thromboendarterectomy.
Keywords
Pulmonary Perfusion, Electrical Impedance Tomography (EIT), Cardiac Output, Resistência Vascular Pulmonar
Medical subject headings
Pulmonary Embolism, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Impedance Tomography (EIT).Diagnostic test

    Non-invasive, radiation-free bedside assessment of pulmonary perfusion using Electrical Impedance Tomography (EIT). EIT will be performed using the Enlight 2100 system (Timpel Medical®, Brazil) in the preoperative and postoperative periods of pulmonary thromboendarterectomy. Pulmonary perfusion will be assessed through analysis of pulsatility signals and first-pass kinetics following hypertonic saline bolus injection, generating regional perfusion maps and quantitative indices, including the wasted ventilatory index. Data will be analyzed offline.

  • Pulmonary Perfusion SPECT-CT.Diagnostic test

    Pulmonary perfusion assessment performed using single-photon emission computed tomography (SPECT) with technetium-99m-labeled macroaggregated albumin, fused with non-contrast chest computed tomography (CT) acquired during both inspiratory and expiratory phases. The fusion of functional perfusion images from SPECT with anatomical images from CT allows regional assessment of pulmonary perfusion and thromboembolic burden. This examination will be performed in the preoperative period and during postoperative follow-up and will serve as a reference imaging modality for comparison with Electrical Impedance Tomography-derived perfusion measures.

  • Pulmonary Thromboendarterectomy.Procedure or surgery

    Pulmonary thromboendarterectomy performed according to standard institutional clinical practice for the treatment of chronic thromboembolic pulmonary hypertension. This surgical procedure is conducted solely for clinical indication and is not investigational. Imaging and monitoring assessments included in this study do not alter the surgical technique or perioperative clinical management.

Study groups in NCT07577700
Study groupRoleWhat they receive
Diagnostic Imaging Ar.ExperimentalPatients with chronic thromboembolic pulmonary hypertension undergoing pulmonary thromboendarterectomy will be evaluated using electrical impedance tomography (EIT) for assessment of regional pulmonary perfusion in the preoperative and postoperative periods. EIT-derived perfusion indices will be analyzed and compared with imaging-based thrombus burden and pulmonary perfusion assessed by SPECT-CT.
Receives: Diagnostic Test: Electrical Impedance Tomography (EIT).; Diagnostic Test: Pulmonary Perfusion SPECT-CT.; Procedure: Pulmonary Thromboendarterectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of perfusion maps obtained by Electrical Impedance Tomography (EIT) in the pre- and postoperative period using the wasted ventilation index..

    Change in pulmonary perfusion assessed by Electrical Impedance Tomography (EIT) using the Enlight 2100 system (Timpel Medical®, Brazil), quantified by the wasted ventilatory index derived from regional perfusion maps, comparing preoperative and postoperative measurements in patients undergoing pulmonary thromboendarterectomy.

    Measured: From the preoperative period to the immediate postoperative period during intensive care unit stay (on the day of surgery).

Secondary outcomes (2)
  1. Comparison of pulmonary perfusion assessed by Electrical Impedance Tomography and SPECT-CT.

    Comparison of changes in regional pulmonary perfusion assessed by Electrical Impedance Tomography (EIT) and by SPECT-CT imaging, expressed as percentage variation between preoperative and postoperative evaluations in patients undergoing pulmonary thromboendarterectomy.

    Measured: From the preoperative period to the postoperative follow-up (up to 6 months after surgery).

  2. Incidence of adverse events related to Electrical Impedance Tomography perfusion assessment.

    Incidence and type of adverse events related to pulmonary perfusion assessment using Electrical Impedance Tomography, including events associated with the use of hypertonic saline injection.

    Measured: From the preoperative period to hospital discharge, up to approximately 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start25 Feb 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
All patients undergoing pulmonary thromboendarterectomy will be evaluated for pulmonary perfusion before and after surgery, as well as for hemodynamic measurements using electrical impedance tomography.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577700
Sponsor's protocol ID
78916224.4.0000.0068
Status last verified
May 2026
First submitted
10 Feb 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zadehkoochak M, Blott BH, Hames TK, George RF. Pulmonary perfusion and ventricular ejection imaging by frequency domain filtering of EIT (electrical impedance tomography) images. Clin Phys Physiol Meas. 1992;13 Suppl A:191-6. doi: 10.1088/0143-0815/13/a/037.

    PubMed 1587100
  • 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.

    PubMed 10847195
  • 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.

    PubMed 14693669
  • 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.

    PubMed 21969018
  • Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.

    PubMed 22700839
  • Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.

    PubMed 25173341
  • Jenkins DP, Madani M, Mayer E, Kerr K, Kim N, Klepetko W, Morsolini M, Dartevelle P. Surgical treatment of chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Mar;41(3):735-42. doi: 10.1183/09031936.00058112. Epub 2012 Nov 8.

    PubMed 23143539
  • Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.

    PubMed 24898545
  • Eyuboglu BM, Brown BH. Methods of cardiac gating applied potential tomography. Clin Phys Physiol Meas. 1988;9 Suppl A:43-8. doi: 10.1088/0143-0815/9/4a/008.

    PubMed 3240648
  • Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

    PubMed 19186406
  • Brown BH. Electrical impedance tomography (EIT): a review. J Med Eng Technol. 2003 May-Jun;27(3):97-108. doi: 10.1080/0309190021000059687.

    PubMed 12775455
  • Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29.

    PubMed 21960654
  • 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.

    PubMed 22240409
  • Barber DC. Quantification in impedance imaging. Clin Phys Physiol Meas. 1990;11 Suppl A:45-56. doi: 10.1088/0143-0815/11/4a/306.

    PubMed 2286047

Questions about this trial

What is this clinical trial studying?

A study testing Electrical Impedance Tomography (EIT)., Pulmonary Perfusion SPECT-CT. and Pulmonary Thromboendarterectomy. in people with Pulmonary Thromboendarterectomy and Pulmonary Embolism and Thrombosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcelo BP Amato, MD PhD (+55113061-7361, marcelo.amato@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of perfusion maps obtained by Electrical Impedance Tomography (EIT) in the pre- and postoperative period using the wasted ventilation index.. (time frame: From the preoperative period to the immediate postoperative period during intensive care unit stay (on the day of surgery).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07577700, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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