Ultra‑high‑resolution CT to look for lung and heart damage in progressive interstitial lung disease

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

This project will use advanced multidimensional CT scans to see if one noninvasive test can measure both lung fibrosis and early heart involvement in adults with progressive or long‑standing interstitial lung disease.

Quick facts

• Study type: Observational
• Enrollment: 123 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT06537934 on ClinicalTrials.gov

What this trial studies

This observational project uses multidimensional and ultra‑high‑resolution computed tomography (CT) to capture detailed images of both the lungs and heart in adults with progressive or long‑standing interstitial lung disease. Participants undergo advanced, contrast‑enhanced CT protocols designed to quantify interstitial fibrosis and to reveal subclinical cardiac changes such as ischemic signs or right ventricular dysfunction. Imaging findings will be compared with clinical history and eligibility data to characterize patterns of cardiopulmonary damage and to explore links between lung disease severity and otherwise unrecognized cardiac injury. The protocol excludes people with known coronary artery disease, cardiac devices, severe renal impairment, active infection, or other listed contraindications, focusing on detection of previously undetected cardiopulmonary involvement.

Who should consider this trial

Good fit: Adults (over 18) with known or strongly suspected ILD—including long‑standing or connective tissue disease–related cases—who can undergo contrast CT and who do not have known coronary artery disease, prior cardiac revascularization, cardiomyopathy, implanted cardiac devices, or severe renal impairment.

Not a fit: People with known coronary artery disease, prior revascularization, implanted cardiac devices, active infection, recent or active cancer, pregnancy or breastfeeding, iodine allergy, severe renal failure (GFR <30 mL/min), or claustrophobia are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could allow earlier, simultaneous detection and staging of lung and heart damage with a single noninvasive scan, improving risk stratification and guiding treatment decisions.

How similar studies have performed: CT-based techniques have been used separately to study lung fibrosis and cardiac disease, but using a single multidimensional ultra‑high‑resolution CT to quantify both heart and lung involvement in ILD is relatively novel and has limited prior data.

Eligibility criteria

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

Where this trial is running

Milan

• IRCCS San Raffaele — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: Anna Palmisano

Conditions Interstitial Lung Diseases; Cardiac fibrosis; Lung interstitial fibrosis