Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06537934
Acronym
AMICI-ILD
Enrollment
123
Registered
2024-08-05
Start date
2024-09-01
Completion date
2026-09-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Diseases

Keywords

Cardiac fibrosis, Lung interstitial fibrosis

Brief 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.

Interventions

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
a low dose image protocol able to characterize ILD related lung parenchyma alteration and new quantitative imaging biomarkers of lung disease severitymonths 2-12

Secondary

MeasureTime frame
the prevalence and the spectrum of cardiac disease (ischemic heart disease, cardiac remodelling and dysfunction in patients with ILD) and the relationship between severity of lung involvement and cardiac injurymonths 3-16
a CT based multiparametric algorithm for risk stratification of patients with ILDmonths 19-24

Countries

Italy

Contacts

Primary ContactAnna Palmisano
palmisano.anna@hsr.it0226436106
Backup ContactAntonio Esposito Esposito
esposito.antonio@hsr.it0226436102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026