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RecruitingNCT07724197EIT-PEUpdated Aug 4, 2026

Pulsatile Electrical Impedance Tomography for Diagnosis and Monitoring of Acute Pulmonary Embolism

An observational study in Pulmonary Embolism Acute, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
275
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 72 studies in Pulmonary Embolism with a site in China — 26 open to participants now, 31 under way, 1 of them phase 3. Pulmonary Embolism · China.

Planned enrollment
34th of 39
275 · median 1,000
Started
2026
with 6 others
Observational
39 of 72
20 open now
Primary completion
2028-06
later than 26 of 30 live
Registered
70th of 72
by date
Lead sponsor
2 of 72
Beijing Tsinghua Chang Gung Hospital

Among the 72 studies in Pulmonary Embolism with a site in China, this one is the 34th largest by planned enrollment of the 39 observational ones, is one of 7 that started in 2026, is one of 39 observational ones, reaches primary completion later than 26 of the 30 other live ones, and was the 70th registered.

By phase

72 studies; the count open now beside each. This study's row is marked.

Observationalthis study39 · 20 open
No phase14 · 5 open
Phase 311 · 1 open
Phase 47 · 0 open
Phase 21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 417 across the 33 interventional studies, 1,000 across the 39 observational. Of the 28 that completed or were terminated, 7 (25%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 72 studies in Pulmonary Embolism with a site in China, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Pulmonary Embolism Acute

Browse trials for

Keywords

  • Acute Pulmonary Embolism
  • Pulsatile Electrical Impedance Tomography
  • Ventilation-Perfusion
  • Risk Stratification
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 less than 50 kg/m², who voluntarily participate and provide written .

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.

Exclusion criteria

Exclusion Criteria:

  • Previous diagnosis of chronic pulmonary embolism or idiopathic pulmonary arterial hypertension.

Acute exacerbation of , acute heart failure, acute myocardial infarction, or other severe cardiopulmonary diseases that may interfere with study assessment.

Pregnancy or lactation. Thoracic deformity. 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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
275 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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.

    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.

    Diagnostic Test: Pulsatile Electrical Impedance Tomography

Interventions

  • Diagnostic testPulsatile Electrical Impedance Tomography

    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.

    Also known as: Pulsatile EIT, Electrical Impedance Tomography, EIT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline or index EIT assessment

Secondary outcomes

  1. 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.

    Time frame: At baseline or index assessment

  2. 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.

    Time frame: At baseline or index assessment

  3. 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.

    Time frame: At baseline or index assessment

  4. 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.

    Time frame: Baseline, 48 hours after thrombolytic treatment when applicable, before discharge, and 1 month after discharge

07

Study locations

1 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jun 2028, 28 months after the start.

Of 135 non-industry observational studies under Pulmonary Embolism, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 119. This study's planned 28 months is below that.

Counting every sponsor, half of 160 studies reached it within 47 months; a quarter within 21 and three quarters within 105.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Jul 24, 2026
StartActual
Jan 2, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Dec 30, 2028
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07724197
Collaborators
Peking Union Medical College Hospital, Tsinghua University, First People's Hospital of Chenzhou, Loudi Central Hospital
Responsible party
Weiwei Wu (Vice President and Chair, Department of Vascular Surgery; Professor and Chief Physician, Beijing Tsinghua Chang Gung Hospital) — Principal investigator
First posted
Jul 24, 2026
Start date
Jan 2, 2026
Primary completion
Jun 1, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Aug 4, 2026

Study contacts

jiazheng Li, MD
Contact
ljzs00357@btch.edu.cn
+86-18810886832
weiwei wu, MD
Contact
weiwei.wu@btch.edu.cn
+86-13426397036
weiwei Wu, MD
principal investigator · Beijing Tsinghua Changgeng Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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