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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Subjects with active infectious disease;

known CAD;

history of previous percutaneous or surgical revascularization;

known cardiomyopathy;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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