Clinical trial NCT06537934: Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases
Official title: Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Interstitial Lung Diseases
Keywords: Cardiac fibrosis
Lung interstitial fibrosis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: 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.

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 any symptoms. 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. Currently, the non-invasive method of reference for ILD diagnosis and monitoring is high resolution Computed Tomography (HRCT) which provide information about lung and airway remodeling, disease severity and pattern. Its application is limited because of the high radiation dose and lack of quantitative early prognosticators; additionally, it does not provide information on cardiovascular disease and cardiac damage. Therefore, cardiologic evaluation is mostly performed in late stages when symptoms are evident and the disease is irreversible. 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. In order to improve patients diagnosis and clinical management since 2016 in our institution, based on a multidisciplinary evaluation including a team made up cardiologist, rheumatologist and radiologist, we applied a single CT study with contrast agent largely validated in several other clinical setting aimed to combine the assessment of chest and cardiac involvement also in this group of patients. However, this approach has limited application in clinical practice by the use of old generation CT scanners, high radiation exposure, limited contrast resolution and by the lack of dedicated postprocessing for the improvement of diagnosis and of the prognostic implication. Novel technology as Dual Energy Computed Tomography (DECT) and Photon Counting CT (PCD-CT) opened to the possibility to improve ILD characterization using spectral information and ultra-high resolution potentially able to identify precursors of lung and cardiac fibrosis, with better image quality at a lower radiation dose. In recent studies was shown the possibility to develop a CT protocol able to simultaneously assess coronary artery, myocardial scar and interstitial fibrosis and to improve risk stratification in COVID-19 pneumonia deriving quantitative biomarker of systemic comorbidities and cardiovascular risk from chest CT, also using artificial intelligence. Based on these evidence aim of the study is to develop a CT protocol using advanced technology (DECT and PCD-CT) able to provide an accurate risk stratification of ILD patients based on a comprehensive evaluation of lung and cardiac damage to quantitatively define the interplay between lung and cardiac remodeling and to identify novel imaging biomarkers useful for prognostication.


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

Primary outcomes:
measure: a low dose image protocol able to characterize ILD related lung parenchyma alteration and new quantitative imaging biomarkers of lung disease severity
timeFrame: months 2-12
Secondary outcomes:
measure: 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
timeFrame: months 3-16
measure: a CT based multiparametric algorithm for risk stratification of patients with ILD
timeFrame: months 19-24
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
Study officials:
References:
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