Predictors of Pulmonary Embolism in Interstitial Lung Disease With Worsening Symptoms

NCT07728448 | Not Yet Recruiting

• 1 other identifier: PE Predictors in ILD Patients
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Rate of Admission to the Respiratory Intensive Care Unit (RICU)

  From hospital admission to hospital discharge, assessed up to 30 days.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pulmonary Embolism; Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pulmonary Fibrosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Chest Diseases Department

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07