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NCT Number: NCT06537934

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

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.

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Key information

Conditions

Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Anna Palmisano Professor Anna Palmisano

CONTACT

[email protected]

0226436106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. a CT based multiparametric algorithm for risk stratification of patients with ILD

    Time frame: months 19-24

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Palmisano

CONTACT

[email protected]

0226436106

Antonio Esposito Esposito

CONTACT

[email protected]

0226436102

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: AMICI-ILD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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