Predictors of Pulmonary Embolism in Interstitial Lung Disease With Worsening Symptoms

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Pregnancy

Previously diagnosed acute pulmonary embolism receiving anticoagulant therapy

Active malignancy

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: ILD with Pulmonary Embolism (Cases)
Group B: ILD without Pulmonary Embolism (Controls)

Trial outcomes

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.

Time frame
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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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