Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases

NCT06537934 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS San Raffaele

Phase

Observational

Started

2024-09-01

Last updated

2026-01-15

Condition(s) studied

Interstitial Lung Diseases

Study summary

Interstitial lung diseases (ILDs) are common chronic disease characterized by high mortality and morbidity, also linked to cardiovascular implication. Cardiovascular complications, occur early in idiopathic pulmonary fibrosis (IPF) and other ILDs without anysymptoms. Symptoms are often misinterpreted and diagnosis delayed to irreversible stages of cardiac dysfunction. Mechanism of cardiac damage, the main cause of mortality, are heterogeneous raging from ischemic heart disease, acceleration of atherosclerosis, to right ventricle dysfunction secondary, to pulmonary hypertension. So an early recognition and accurate staging are fundamental to avoid disease progression and improve outcomes. The identification of a single non-invasive imaging modality able to simultaneously characterize in an accurate and quantitative way the entity of lung and cardiac damage in patients affected by ILD would be useful to improve risk stratification and to guide treatment.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: • Adult subjects (\>18 y.o.) with previously known ILD or high likelihood for having ILD including CTD diagnosis since at least 5 years before the project starts in order to increase the prevalence of ILD \[2\] who signed an Informed Consent authorizing data collection. Exclusion Criteria: * Subjects with active infectious disease; * known CAD; * history of previous percutaneous or surgical revascularization; * known cardiomyopathy; * previous heart failure; * presence of cardiac devices (prosthetic valve, ICD, PM, ICD-CRT, LVAD) * previous or active neoplasia; * pregnancy and breastfeeding; * allergy to iodine contrast agent; * claustrophobia; * glomerular filtration rate \< 30mL/min * impossibility to lay down or breath old * absence of informed consent signed

Primary outcome measure(s)

a low dose image protocol able to characterize ILD related lung parenchyma alteration and new quantitative imaging biomarkers of lung disease severity — months 2-12

Trial sites (1)

Facility	City	Region	Status
IRCCS San Raffaele	Milan	Italy	Recruiting

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Other trials for the same condition

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases Recruiting

Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank Active, not recruiting

Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis Recruiting

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06537934 on ClinicalTrials.gov ↗ ← All trials in Italy