Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Predictors of Pulmonary Embolism in Interstitial Lung Disease With Worsening Symptoms

keskiviikko 22. heinäkuuta 2026 päivittänyt: Ziad Abd Elhady Sayed Abd Elaal, Assiut University

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.

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

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

70

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei käytössä

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Presence of Acute Pulmonary Embolism
Aikaikkuna: 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.
Baseline

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Rate of Admission to the Respiratory Intensive Care Unit (RICU)
Aikaikkuna: From hospital admission to hospital discharge, assessed up to 30 days.
The proportion of patients requiring admission to the Respiratory Intensive Care Unit (RICU) for advanced management during their acute worsening respiratory episode.
From hospital admission to hospital discharge, assessed up to 30 days.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Lauantai 1. elokuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Sunnuntai 1. elokuuta 2027

Opintojen valmistuminen (Arvioitu)

Keskiviikko 1. syyskuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 22. heinäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 22. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 27. heinäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 27. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 22. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa