Pulmonary Embolism AcuteEIT-PENCT07724197
Pulsatile Electrical Impedance Tomography for Diagnosis and Monitoring of Acute Pulmonary Embolism
An observational study of Pulmonary Embolism Acute, run by Beijing Tsinghua Chang Gung Hospital at 4 sites in China.
Trial summary
This multicenter observational diagnostic study aims to evaluate pulsatile electrical impedance tomography (EIT) for the diagnosis and monitoring of acute pulmonary embolism. The study includes a retrospective phase and a prospective phase. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- Pulsatile Electrical Impedance Tomography
- How many people
- 275 participants
- Where
- 4 sitesChina
- Study dates
- 2 Jan 2026to 30 Dec 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes adults with acute pulmonary embolism and control participants from the retrospective and prospective phases. Retrospective participants include patients with CTPA-confirmed acute pulmonary embolism and healthy controls with available EIT and clinical data. Prospective participants include patients newly diagnosed with acute pulmonary embolism and patients with suspected acute pulmonary embolism in whom pulmonary embolism is not confirmed by CTPA or CTPA plus CTV. All prospective participants will provide written informed consent.
Who may be able to join
- Adults aged 18 years or older. For retrospective PE cases: patients with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination, adequate image data, and available clinical information.
- For retrospective healthy controls: adults without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history.
- For prospective PE patients: patients newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, with body mass index less than 50 kg/m², who voluntarily participate and provide written informed consent.
- For prospective non-PE controls: patients with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed, who voluntarily participate and provide written informed consent.
Who cannot join
- Previous diagnosis of chronic pulmonary embolism or idiopathic pulmonary arterial hypertension.
- Acute exacerbation of chronic obstructive pulmonary disease, acute heart failure, acute myocardial infarction, or other severe cardiopulmonary diseases that may interfere with study assessment.
- Pregnancy or lactation. Thoracic deformity. Contraindications to EIT examination, including automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implanted pumps, or other conditions unsuitable for EIT electrode belt placement.
- Participation in another clinical trial during the same period, for prospective participants.
- Unstable vital signs requiring emergency rescue, leaving no time to complete EIT examination, for prospective participants.
- Any other condition considered unsuitable for participation by the investigators.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
YUN LONG, MD, +86-10-69155707, 2801634102@qq.com
yun long, MD
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
weiwei wu, MD, +86-13426397036, weiwei.wu@btch.edu.cn
jiazheng LI, MD, +86-18810886832, ljzs00357@btch.edu.cn
- Recruiting
Chenzhou First People's Hospital
Chenzhou, Hunan, 423000
shaofei xu, MD, +86-13617356697, 742025632@qq.com
742025632@qq.com
- Not yet recruiting
Loudi Central Hospital
Loudi, Hunan, 417000
junbiao huang, MD, +8618873820320, 695997696@qq.com
junbiao huang, MD
About this study
Official title: A Multicenter Retrospective and Prospective Diagnostic Observational Study of Pulsatile Electrical Impedance Tomography for Diagnosis, Risk Stratification, and Dynamic Monitoring of Acute Pulmonary Embolism
This multicenter observational diagnostic study aims to evaluate pulsatile electrical impedance tomography (EIT) for the diagnosis and monitoring of acute pulmonary embolism. The study includes a retrospective phase and a prospective phase. EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index will be compared with CT pulmonary angiography and relevant clinical indicators. The study is designed to assess whether EIT can provide a noninvasive, bedside, radiation-free method for pulmonary embolism diagnosis, risk stratification, and dynamic treatment monitoring.
Read the detailed description
Pulmonary embolism is an important type of venous thromboembolism and may be associated with substantial morbidity and mortality. CT pulmonary angiography is commonly used as the reference standard for diagnosis, but it has limitations, including radiation exposure, use of iodinated contrast agents, and limited feasibility for continuous bedside monitoring in some critically ill patients.
Electrical impedance tomography is a noninvasive functional imaging technique that can be performed at the bedside and does not involve radiation. This study will evaluate a pulsatile EIT-based approach for assessing pulmonary ventilation and perfusion. The main EIT-derived parameters include the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
The retrospective phase will collect existing clinical and EIT data from patients with CTPA-confirmed acute pulmonary embolism and healthy controls. These data will be used to compare EIT parameters between groups, evaluate diagnostic performance, and explore optimal cutoff values.
The prospective phase will enroll patients newly diagnosed with acute pulmonary embolism and healthy volunteers. EIT examinations will be performed during routine clinical evaluation and follow-up. EIT parameters will be compared with CTPA findings, clinical risk stratification, D-dimer levels, echocardiographic indicators, and clinical outcomes. For patients with pulmonary embolism, serial EIT measurements may be used to evaluate dynamic changes during treatment and follow-up.
This is an observational study. Participants will not be assigned to any treatment by the study protocol, and clinical management will be determined by the treating physicians according to routine clinical practice.
- Conditions
- Pulmonary Embolism Acute
- Being tested
- Pulsatile Electrical Impedance Tomography
- Keywords
- Acute Pulmonary Embolism, Pulsatile Electrical Impedance Tomography, Ventilation-Perfusion, Risk Stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile Electrical Impedance TomographyDiagnostic test
Also called Pulsatile EIT, Electrical Impedance Tomography, EIT
Pulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective PE Cases | Patients aged 18 years or older with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination and available clinical data in the retrospective phase. Receives: Diagnostic Test: Pulsatile Electrical Impedance Tomography | |
| Retrospective Healthy Controls | Adults in the retrospective phase without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history. Receives: Diagnostic Test: Pulsatile Electrical Impedance Tomography | |
| Prospective PE Patients | Patients aged 18 years or older newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, who voluntarily participate and provide written informed consent. Receives: Diagnostic Test: Pulsatile Electrical Impedance Tomography | |
| Prospective Non-PE Controls | Patients aged 18 years or older with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed. These participants voluntarily participate and provide written informed consent in the prospective phase. Receives: Diagnostic Test: Pulsatile Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism
The diagnostic performance of EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index for distinguishing acute pulmonary embolism from non-PE controls will be evaluated using the area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, negative predictive value, and optimal cutoff values, with CT pulmonary angiography as the reference standard.
Measured: At baseline or index EIT assessment
Secondary outcomes (4)
Correlation between EIT-derived parameters and CTPA embolic burden
The correlation between MI, DI, SI and the embolic burden assessed by CT pulmonary angiography will be analyzed.
Measured: At baseline or index assessment
Differences in EIT-derived parameters across thrombus locations and clinical risk strata
MI, DI, and SI will be compared among patients with different thrombus locations and different clinical risk strata.
Measured: At baseline or index assessment
Correlation between EIT-derived parameters and clinical indicators
The correlation between MI, DI, SI and clinical indicators, including D-dimer levels and echocardiographic indicators of right heart function, will be analyzed.
Measured: At baseline or index assessment
Dynamic changes in EIT-derived parameters during treatment and follow-up
Changes and percentage changes in MI, DI, and SI will be assessed at baseline, during treatment when applicable, before discharge, and at 1 month after discharge.
Measured: Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start2 Jan 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Tsinghua University, First People's Hospital of Chenzhou, Loudi Central Hospital
- Responsible party
- Principal investigator, Weiwei Wu, Beijing Tsinghua Chang Gung Hospital
- Investigators
- weiwei Wu, MD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724197
- Sponsor's protocol ID
- 2D-EIT-PE-2026
- Other IDs
- L246021, 26890-0-01
- Acronym
- EIT-PE
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective and Prospective Diagnostic Observational Study of Pulsatile Electrical Impedance Tomography for Diagnosis, Risk Stratification, and Dynamic Monitoring of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07724197
- Acronym / sponsor ID
- EIT-PE / 2D-EIT-PE-2026
- Conditions
- Pulmonary Embolism Acute
- Keywords
- Acute Pulmonary Embolism, Pulsatile Electrical Impedance Tomography, Ventilation-Perfusion, Risk Stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Tsinghua University, First People's Hospital of Chenzhou, Loudi Central Hospital
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter observational diagnostic study aims to evaluate pulsatile electrical impedance tomography (EIT) for the diagnosis and monitoring of acute pulmonary embolism. The study includes a retrospective phase and a prospective phase. EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index will be compared with CT pulmonary angiography and relevant clinical indicators. The study is designed to assess whether EIT can provide a noninvasive, bedside, radiation-free method for pulmonary embolism diagnosis, risk stratification, and dynamic treatment monitoring.
Detailed description
Pulmonary embolism is an important type of venous thromboembolism and may be associated with substantial morbidity and mortality. CT pulmonary angiography is commonly used as the reference standard for diagnosis, but it has limitations, including radiation exposure, use of iodinated contrast agents, and limited feasibility for continuous bedside monitoring in some critically ill patients.
Electrical impedance tomography is a noninvasive functional imaging technique that can be performed at the bedside and does not involve radiation. This study will evaluate a pulsatile EIT-based approach for assessing pulmonary ventilation and perfusion. The main EIT-derived parameters include the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index.
The retrospective phase will collect existing clinical and EIT data from patients with CTPA-confirmed acute pulmonary embolism and healthy controls. These data will be used to compare EIT parameters between groups, evaluate diagnostic performance, and explore optimal cutoff values.
The prospective phase will enroll patients newly diagnosed with acute pulmonary embolism and healthy volunteers. EIT examinations will be performed during routine clinical evaluation and follow-up. EIT parameters will be compared with CTPA findings, clinical risk stratification, D-dimer levels, echocardiographic indicators, and clinical outcomes. For patients with pulmonary embolism, serial EIT measurements may be used to evaluate dynamic changes during treatment and follow-up.
This is an observational study. Participants will not be assigned to any treatment by the study protocol, and clinical management will be determined by the treating physicians according to routine clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retrospective PE Cases | – | Diagnostic Test: Pulsatile Electrical Impedance TomographyPatients aged 18 years or older with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination and available clinical data in the retrospective phase. |
| Retrospective Healthy Controls | – | Diagnostic Test: Pulsatile Electrical Impedance TomographyAdults in the retrospective phase without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history. |
| Prospective PE Patients | – | Diagnostic Test: Pulsatile Electrical Impedance TomographyPatients aged 18 years or older newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, who voluntarily participate and provide written informed consent. |
| Prospective Non-PE Controls | – | Diagnostic Test: Pulsatile Electrical Impedance TomographyPatients aged 18 years or older with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed. These participants voluntarily participate and provide written informed consent in the prospective phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults with acute pulmonary embolism and control participants from the retrospective and prospective phases. Retrospective participants include patients with CTPA-confirmed acute pulmonary embolism and healthy controls with available EIT and clinical data. Prospective participants include patients newly diagnosed with acute pulmonary embolism and patients with suspected acute pulmonary embolism in whom pulmonary embolism is not confirmed by CTPA or CTPA plus CTV. All prospective participants will provide written informed consent.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older. For retrospective PE cases: patients with acute pulmonary embolism confirmed by CT pulmonary angiography, with completed pulsatile electrical impedance tomography examination, adequate image data, and available clinical information.
- For retrospective healthy controls: adults without evidence of lower-extremity venous thrombosis, with normal D-dimer levels, simplified Wells score ≤1, and no pulmonary embolism-related symptoms or history.
- For prospective PE patients: patients newly diagnosed with pulmonary embolism by CT pulmonary angiography or CT pulmonary angiography plus CT venography, with body mass index less than 50 kg/m², who voluntarily participate and provide written informed consent.
- For prospective non-PE controls: patients with suspected acute pulmonary embolism who undergo CT pulmonary angiography or CT pulmonary angiography plus CT venography, but in whom pulmonary embolism is not confirmed, who voluntarily participate and provide written informed consent.
Key exclusion criteria (6 listed)
- Previous diagnosis of chronic pulmonary embolism or idiopathic pulmonary arterial hypertension.
- Acute exacerbation of chronic obstructive pulmonary disease, acute heart failure, acute myocardial infarction, or other severe cardiopulmonary diseases that may interfere with study assessment.
- Pregnancy or lactation. Thoracic deformity. Contraindications to EIT examination, including automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implanted pumps, or other conditions unsuitable for EIT electrode belt placement.
- Participation in another clinical trial during the same period, for prospective participants.
- Unstable vital signs requiring emergency rescue, leaving no time to complete EIT examination, for prospective participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile Electrical Impedance TomographyAlso: Pulsatile EIT, Electrical Impedance Tomography, EITPulsatile electrical impedance tomography will be used to obtain EIT-derived parameters, including the ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index. These parameters will be compared with CT pulmonary angiography and clinical indicators to evaluate the diagnostic performance, risk stratification value, and dynamic monitoring value of EIT in acute pulmonary embolism. This diagnostic assessment does not assign participants to treatment and does not alter routine clinical management. | Diagnostic test | Prospective Non-PE Controls, Prospective PE Patients, Retrospective Healthy Controls, Retrospective PE Cases |
Primary outcome
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism
Time frame: At baseline or index EIT assessment
The diagnostic performance of EIT-derived ventilation-perfusion matching index, dead-space ventilation index, and intrapulmonary shunt index for distinguishing acute pulmonary embolism from non-PE controls will be evaluated using the area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, negative predictive value, and optimal cutoff values, with CT pulmonary angiography as the reference standard.
4 secondary outcomes
Correlation between EIT-derived parameters and CTPA embolic burden
Time frame: At baseline or index assessment
Differences in EIT-derived parameters across thrombus locations and clinical risk strata
Time frame: At baseline or index assessment
Correlation between EIT-derived parameters and clinical indicators
Time frame: At baseline or index assessment
Dynamic changes in EIT-derived parameters during treatment and follow-up
Time frame: Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
weiwei Wu, MD principal investigator
Beijing Tsinghua Changgeng Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism Acute, run by Beijing Tsinghua Chang Gung Hospital at 4 sites in China.
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 4 inclusion and 6 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 jiazheng Li, MD (+86-18810886832, ljzs00357@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of EIT-derived MI, DI, and SI for acute pulmonary embolism (time frame: At baseline or index EIT assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.