Actively Recruiting

Age: 18Years +
All Genders
ID06537934

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

Led by IRCCS San Raffaele · Updated on 2026-01-15

123

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying interstitial lung diseases (ILDs), a group of chronic conditions that cause serious lung and heart problems, including early heart complications that often go unnoticed. These heart issues can include ischemic heart disease, worsening of artery health, and right heart dysfunction due to high lung blood pressure. Early detection and accurate assessment of both lung and heart damage are important to prevent disease worsening and improve patient outcomes. The study is observational and uses advanced multidimensional and ultra-high resolution computed tomography (CT) scans to non-invasively evaluate and measure lung and heart damage in patients with progressive fibrosing ILDs. The goal is to develop a low-dose CT imaging protocol that can characterize lung tissue changes and discover new imaging biomarkers of lung disease severity. Additionally, researchers aim to study the prevalence and types of heart disease in ILD patients and create a CT-based risk assessment tool. Participants will undergo CT scans over a period of months to measure lung and heart conditions using these new imaging methods. The main focus is to assess lung tissue damage between months 2 and 12, then evaluate heart disease features and their link to lung severity between months 3 and 16. Later, a multiparametric CT algorithm for risk stratification will be developed from months 19 to 24. Throughout the study, data collection will be done with informed consent, and participants will be monitored for safety and disease progression.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • Known or highly likely interstitial lung disease or connective tissue disease for at least 5 years before the study
  • Signed informed consent to allow data collection
Not Eligible

You will not qualify if you...

  • Active infectious disease
  • Known coronary artery disease
  • History of prior heart procedures like revascularization
  • Known cardiomyopathy
  • Previous heart failure
  • Presence of cardiac devices such as prosthetic valves, pacemakers, defibrillators, or ventricular assist devices
  • Previous or current cancer
  • Pregnancy or breastfeeding
  • Allergy to iodine contrast agents
  • Claustrophobia
  • Severe kidney dysfunction with glomerular filtration rate below 30 mL/min
  • Inability to lie down or hold breath during imaging
  • No signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 24 months

Participants undergo advanced multidimensional and ultra high resolution computed tomography to assess cardiopulmonary involvement in their lung disease.

Imaging visits occurring between months 2 and 24

Long-term Monitoring

Duration - Up to 24 months

Participants are observed over time to evaluate disease progression and cardiac injury related to their lung condition.

Periodic assessments up to month 24

Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele

Milan, Italy, 20132

Actively Recruiting

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Research Team

A

Anna Palmisano

A

Antonio Esposito Esposito

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Cardiovascular complications in patients with interstitial lung disease and their correlation with 6-minute walk test and spirometry: A single-center study.

Saurabh Gupta, Prasanta Padhan, Saswat Subhankar...

https://pubmed.ncbi.nlm.nih.gov/34760753

Chest CT opportunistic biomarkers for phenotyping high-risk COVID-19 patients: a retrospective multicentre study.

Anna Palmisano, Chiara Gnasso, Alberto Cereda...

https://pubmed.ncbi.nlm.nih.gov/37166497

"Quadruple Rule-Out" With Computed Tomography in a COVID-19 Patient With Equivocal Acute Coronary Syndrome Presentation.

Gianluca Pontone, Andrea Baggiano, Edoardo Conte...

https://pubmed.ncbi.nlm.nih.gov/32762888