Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases (AMICI-ILD)

January 14, 2026 updated by: Anna Palmisano, IRCCS San Raffaele
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

123 patients will be submitted to standard of care imaging and the informed consent is required for the authorization to use the imaging data for scientific purpose and to collected clinical and laboratory data using electronic medical records, and clinical interview.

All patients will undergo echocardiography, as clinically indicated, that will be performed in accordance with the most recent guidelines for a comprehensive morphofuctional assessment of cardiac chambers, valves, evaluation of pulmonary hypertension and associated remodeling, including the identification of subtle myocardial deformation alteration using strain analysis. Hence, CT will be compared to echocardiography, currently indicated for the monitoring of CTD, in order to establish agreement and potential additional information. Hence, only a subgroup of 74 patients who have an altered troponin T value (> 14 ng/L) will undergo cardiac magnetic resonance imaging (CMR) according to clinical practice.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time 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 injury
Time Frame: months 3-16
months 3-16
a CT based multiparametric algorithm for risk stratification of patients with ILD
Time Frame: months 19-24
months 19-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNRR-MCNT2- 2023-12377844

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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