Pulmonary EmbolismNCT07728448
Predictors of Pulmonary Embolism in Interstitial Lung Disease With Worsening Symptoms
An observational study of Pulmonary Embolism and Interstitial Lung Disease, run by Assiut University.
Trial summary
People with interstitial lung disease (ILD) can sometimes experience a sudden and severe worsening of their breathing. While this can be caused by a flare-up of the lung disease itself, it can also be caused by a blood clot in the lungs, known as a pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- 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
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older) with a confirmed diagnosis of interstitial lung disease (ILD) who are admitted to the Chest Department and Respiratory Intensive Care Unit at Assiut University Hospital, Egypt. Eligible participants are those presenting with an acute, unexplained worsening of respiratory symptoms, such as dyspnea, hypoxemia, chest pain, or syncope, or those who have a clinical suspicion of pulmonary embolism and are undergoing Computed Tomography Pulmonary Angiography (CTPA) as part of their routine clinical care.
Who may be able to join
- Age ≥ 18 years
- Confirmed diagnosis of ILD based on multidisciplinary discussion and HRCT findings, with or without histopathological confirmation
- Acute unexplained worsening of dyspnea, hypoxemia, chest pain, syncope, or clinical suspicion of PE
- Undergoing CTPA as part of routine clinical management
- Provision of informed consent
Who cannot join
- Age < 18 years
- Pregnancy
- Previously diagnosed acute pulmonary embolism receiving anticoagulant therapy
- Active malignancy
- Known inherited or acquired thrombophilia
- Acute myocardial infarction or ischemic stroke within the previous month
- Major surgery or trauma within four weeks
- Severe renal impairment contraindicating contrast-enhanced CTPA
About this study
Official title: Predictors of Pulmonary Embolism in Patients With Interstitial Lung Diseases Presenting With Worsening Respiratory Symptoms
People with interstitial lung disease (ILD) can sometimes experience a sudden and severe worsening of their breathing. While this can be caused by a flare-up of the lung disease itself, it can also be caused by a blood clot in the lungs, known as a pulmonary embolism (PE). It is often difficult for doctors to tell the difference between these two emergencies because their symptoms, such as shortness of breath and low oxygen levels, are very similar. Traditional scoring systems used to predict blood clots are often less accurate for patients who already have chronic lung diseases like ILD.
The main goal of this observational study is to find better, more reliable ways to predict which ILD patients with worsening breathing symptoms actually have a pulmonary embolism.
Read more
Researchers will observe 70 adult patients with ILD who come to the hospital with a sudden worsening of their symptoms (such as shortness of breath, chest pain, or low oxygen) and who require a specific type of CT scan (Computed Tomography Pulmonary Angiography, or CTPA) as part of their standard medical care to check for blood clots.
The study will compare the patients whose CT scan confirms a blood clot to those whose scan does not show a clot. By comparing these two groups, the research team will evaluate various clinical signs, routine blood tests, novel inflammatory markers, and heart/lung imaging details.
Identifying strong predictors of pulmonary embolism in this specific group of patients could help doctors diagnose lung blood clots faster and more accurately, leading to better clinical decision-making and improved patient outcomes
Read the detailed description
Interstitial lung diseases (ILDs) comprise a heterogeneous group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis, often leading to progressive respiratory failure. Patients with ILD carry a heightened risk of venous thromboembolism, specifically pulmonary embolism (PE), driven by chronic inflammation, endothelial dysfunction, hypoxemia, reduced mobility, and a systemic pro-thrombotic state. The development of PE in ILD patients is associated with prolonged hospitalization, increased morbidity, and poor survival outcomes.
Diagnosing PE in this specific population remains clinically challenging because the acute manifestations, such as worsening dyspnea and hypoxemia, closely mimic those of an acute ILD exacerbation. Furthermore, conventional clinical prediction models, such as the Wells and Revised Geneva scores, frequently exhibit limited diagnostic accuracy in this cohort because respiratory distress and baseline hypoxia are already common underlying features of ILD.
To address this diagnostic gap, this prospective observational study will evaluate patients with a confirmed diagnosis of ILD who present with an acute, unexplained worsening of respiratory symptoms and undergo Computed Tomography Pulmonary Angiography (CTPA).
Comprehensive clinical, laboratory, and radiological data will be systematically collected for all participants to identify independent predictors of PE. The study workflow includes:
- Clinical Scoring: Calculation of established pre-test probability and mortality risk scores, including the traditional and simplified Wells score, Revised Geneva score, Pulmonary Embolism Severity Index (PESI), and Simplified PESI (SPESI).
- Laboratory Assessment: Evaluation of novel inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Additional laboratory profiling includes D-dimer, C-reactive protein (CRP), serum total protein, serum albumin, renal and liver function tests, and arterial blood gas analysis to calculate the A-a oxygen gradient.
- Radiological \& Echocardiographic Evaluation: High-Resolution CT (HRCT) will be used to quantify ILD disease severity and extent via the Warrick Score. CTPA scans will be analyzed for embolus location, right ventricular (RV) diameter, RV/LV diameter ratio, and main pulmonary artery diameter. When available, transthoracic echocardiography will assess RV size and systolic function, TAPSE, fractional area change, McConnell sign, the 60/60 sign, and inferior vena cava collapsibility.
Through multivariable logistic regression and Receiver Operating Characteristic (ROC) curve analysis, the study will compare these parameters between patients with CTPA-confirmed PE and those with negative scans. The goal is to validate the predictive strength of these biomarkers and imaging parameters, supporting the development of a disease-specific diagnostic prediction model to enhance clinical decision-making for ILD patients.
- Conditions
- Pulmonary Embolism, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Disease-associated Interstitial Lung Disease
- Keywords
- Predictors, Inflammatory Biomarkers, Worsening Respiratory Symptoms, Computed Tomography Pulmonary Angiography (CTPA), Acute Exacerbation
- Medical subject headings
- Pulmonary Embolism, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ILD with Pulmonary Embolism (Cases) | This group consists of adult patients (aged 18 years and older) with a confirmed diagnosis of Interstitial Lung Disease (ILD) who present with an acute unexplained worsening of respiratory symptoms (such as dyspnea, hypoxemia, chest pain, or syncope). These patients undergo Computed Tomography Pulmonary Angiography (CTPA) as part of routine clinical management and are confirmed to have acute pulmonary embolism. | |
| ILD without Pulmonary Embolism (Controls) | This group consists of adult patients (aged 18 years and older) with a confirmed diagnosis of Interstitial Lung Disease (ILD) who present with an acute unexplained worsening of respiratory symptoms (such as dyspnea, hypoxemia, chest pain, or syncope). These patients undergo Computed Tomography Pulmonary Angiography (CTPA) as part of routine clinical management but have negative findings, confirming the absence of acute pulmonary embolism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Acute Pulmonary Embolism
The primary outcome is the binary assessment (presence or absence) of an acute pulmonary embolism, which is definitively diagnosed and confirmed using Computed Tomography Pulmonary Angiography (CTPA) imaging.
Measured: Baseline
Secondary outcomes (1)
Rate of Admission to the Respiratory Intensive Care Unit (RICU)
The proportion of patients requiring admission to the Respiratory Intensive Care Unit (RICU) for advanced management during their acute worsening respiratory episode.
Measured: From hospital admission to hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Abd Elhady Sayed Abd Elaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728448
- Sponsor's protocol ID
- PE Predictors in ILD Patients
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pulmonary Embolism in Patients With Interstitial Lung Diseases Presenting With Worsening Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT07728448
- Acronym / sponsor ID
- PE Predictors in ILD Patients
- Conditions
- Pulmonary Embolism, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Disease-associated Interstitial Lung Disease
- Keywords
- Predictors, Inflammatory Biomarkers, Worsening Respiratory Symptoms, Computed Tomography Pulmonary Angiography (CTPA), Acute Exacerbation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 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.
People with interstitial lung disease (ILD) can sometimes experience a sudden and severe worsening of their breathing. While this can be caused by a flare-up of the lung disease itself, it can also be caused by a blood clot in the lungs, known as a pulmonary embolism (PE). It is often difficult for doctors to tell the difference between these two emergencies because their symptoms, such as shortness of breath and low oxygen levels, are very similar. Traditional scoring systems used to predict blood clots are often less accurate for patients who already have chronic lung diseases like ILD.
The main goal of this observational study is to find better, more reliable ways to predict which ILD patients with worsening breathing symptoms actually have a pulmonary embolism.
Researchers will observe 70 adult patients with ILD who come to the hospital with a sudden worsening of their symptoms (such as shortness of breath, chest pain, or low oxygen) and who require a specific type of CT scan (Computed Tomography Pulmonary Angiography, or CTPA) as part of their standard medical care to check for blood clots.
The study will compare the patients whose CT scan confirms a blood clot to those whose scan does not show a clot. By comparing these two groups, the research team will evaluate various clinical signs, routine blood tests, novel inflammatory markers, and heart/lung imaging details.
Identifying strong predictors of pulmonary embolism in this specific group of patients could help doctors diagnose lung blood clots faster and more accurately, leading to better clinical decision-making and improved patient outcomes
Detailed description
Interstitial lung diseases (ILDs) comprise a heterogeneous group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis, often leading to progressive respiratory failure. Patients with ILD carry a heightened risk of venous thromboembolism, specifically pulmonary embolism (PE), driven by chronic inflammation, endothelial dysfunction, hypoxemia, reduced mobility, and a systemic pro-thrombotic state. The development of PE in ILD patients is associated with prolonged hospitalization, increased morbidity, and poor survival outcomes.
Diagnosing PE in this specific population remains clinically challenging because the acute manifestations, such as worsening dyspnea and hypoxemia, closely mimic those of an acute ILD exacerbation. Furthermore, conventional clinical prediction models, such as the Wells and Revised Geneva scores, frequently exhibit limited diagnostic accuracy in this cohort because respiratory distress and baseline hypoxia are already common underlying features of ILD.
To address this diagnostic gap, this prospective observational study will evaluate patients with a confirmed diagnosis of ILD who present with an acute, unexplained worsening of respiratory symptoms and undergo Computed Tomography Pulmonary Angiography (CTPA).
Comprehensive clinical, laboratory, and radiological data will be systematically collected for all participants to identify independent predictors of PE. The study workflow includes:
- Clinical Scoring: Calculation of established pre-test probability and mortality risk scores, including the traditional and simplified Wells score, Revised Geneva score, Pulmonary Embolism Severity Index (PESI), and Simplified PESI (SPESI).
- Laboratory Assessment: Evaluation of novel inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Additional laboratory profiling includes D-dimer, C-reactive protein (CRP), serum total protein, serum albumin, renal and liver function tests, and arterial blood gas analysis to calculate the A-a oxygen gradient.
- Radiological \& Echocardiographic Evaluation: High-Resolution CT (HRCT) will be used to quantify ILD disease severity and extent via the Warrick Score. CTPA scans will be analyzed for embolus location, right ventricular (RV) diameter, RV/LV diameter ratio, and main pulmonary artery diameter. When available, transthoracic echocardiography will assess RV size and systolic function, TAPSE, fractional area change, McConnell sign, the 60/60 sign, and inferior vena cava collapsibility.
Through multivariable logistic regression and Receiver Operating Characteristic (ROC) curve analysis, the study will compare these parameters between patients with CTPA-confirmed PE and those with negative scans. The goal is to validate the predictive strength of these biomarkers and imaging parameters, supporting the development of a disease-specific diagnostic prediction model to enhance clinical decision-making for ILD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILD with Pulmonary Embolism (Cases) | – | –This group consists of adult patients (aged 18 years and older) with a confirmed diagnosis of Interstitial Lung Disease (ILD) who present with an acute unexplained worsening of respiratory symptoms (such as dyspnea, hypoxemia, chest pain, or syncope). These patients undergo Computed Tomography Pulmonary Angiography (CTPA) as part of routine clinical management and are confirmed to have acute pulmonary embolism. |
| ILD without Pulmonary Embolism (Controls) | – | –This group consists of adult patients (aged 18 years and older) with a confirmed diagnosis of Interstitial Lung Disease (ILD) who present with an acute unexplained worsening of respiratory symptoms (such as dyspnea, hypoxemia, chest pain, or syncope). These patients undergo Computed Tomography Pulmonary Angiography (CTPA) as part of routine clinical management but have negative findings, confirming the absence of acute pulmonary embolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) with a confirmed diagnosis of interstitial lung disease (ILD) who are admitted to the Chest Department and Respiratory Intensive Care Unit at Assiut University Hospital, Egypt. Eligible participants are those presenting with an acute, unexplained worsening of respiratory symptoms, such as dyspnea, hypoxemia, chest pain, or syncope, or those who have a clinical suspicion of pulmonary embolism and are undergoing Computed Tomography Pulmonary Angiography (CTPA) as part of their routine clinical care.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Confirmed diagnosis of ILD based on multidisciplinary discussion and HRCT findings, with or without histopathological confirmation
- Acute unexplained worsening of dyspnea, hypoxemia, chest pain, syncope, or clinical suspicion of PE
- Undergoing CTPA as part of routine clinical management
- Provision of informed consent
Key exclusion criteria (8 listed)
- Age < 18 years
- Pregnancy
- Previously diagnosed acute pulmonary embolism receiving anticoagulant therapy
- Active malignancy
- Known inherited or acquired thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Acute Pulmonary Embolism
Time frame: Baseline
The primary outcome is the binary assessment (presence or absence) of an acute pulmonary embolism, which is definitively diagnosed and confirmed using Computed Tomography Pulmonary Angiography (CTPA) imaging.
1 secondary outcome
Rate of Admission to the Respiratory Intensive Care Unit (RICU)
Time frame: From hospital admission to hospital discharge, assessed up to 30 days.
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 27 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Interstitial Lung Disease, run by Assiut University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Acute Pulmonary Embolism (time frame: Baseline). 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 27 Jul 2026.