Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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 outcome measures (2)
- 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]
- a CT based multiparametric algorithm for risk stratification of patients with ILD [Time frame: months 19-24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele — Milan
Publications
- Wells AU, Brown KK, Flaherty KR, Kolb M, Thannickal VJ; IPF Consensus Working Group. What's in a name? That which we call IPF, by any other name would act the same. Eur Respir J. 2018 May 17;51(5):1800692. doi: 10.1183/13993003.00692-2018. Print 2018 May. PMID 29773608
- Sauleda J, Nunez B, Sala E, Soriano JB. Idiopathic Pulmonary Fibrosis: Epidemiology, Natural History, Phenotypes. Med Sci (Basel). 2018 Nov 29;6(4):110. doi: 10.3390/medsci6040110. PMID 30501130
- Gupta S, Padhan P, Subhankar S, Singh P. Cardiovascular complications in patients with interstitial lung disease and their correlation with 6-minute walk test and spirometry: A single-center study. J Family Med Prim Care. 2021 Sep;10(9):3330-3335. doi: 10.4103/jfmpc.jfmpc_350_21. Epub 2021 Sep 30. PMID 34760753
- Raghu G, Amatto VC, Behr J, Stowasser S. Comorbidities in idiopathic pulmonary fibrosis patients: a systematic literature review. Eur Respir J. 2015 Oct;46(4):1113-30. doi: 10.1183/13993003.02316-2014. PMID 26424523
- Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic So PMID 30168753
- Gaillandre Y, Duhamel A, Flohr T, Faivre JB, Khung S, Hutt A, Felloni P, Remy J, Remy-Jardin M. Ultra-high resolution CT imaging of interstitial lung disease: impact of photon-counting CT in 112 patients. Eur Radiol. 2023 Aug;33(8):5528-5539. doi: 10.1007/s00330-023-09616-x. Epub 2023 Apr 18. PMID 37071165
- Palmisano A, Vignale D, Tadic M, Moroni F, De Stefano D, Gatti M, Boccia E, Faletti R, Oppizzi M, Peretto G, Slavich M, Sala S, Montorfano M, Agricola E, Margonato A, De Cobelli F, Gentile F, Robella M, Cortese G, Esposito A. Myocardial Late Contrast Enhancement CT in Troponin-Positive Acute Chest Pain Syndrome. Radiology. 2022 Mar;302(3):545-553. doi: 10.1148/radiol.211288. Epub 2021 Dec 7. PMID 34874200
- Vignale D, Palmisano A, Colantoni C, Brunetti L, Nicoletti V, Gnasso C, Esposito A. Toward a One-Stop Shop CT Protocol in Acute Chest Pain Syndrome. Radiology. 2023 Jan;306(1):E3-E4. doi: 10.1148/radiol.220844. Epub 2022 Sep 27. No abstract available. PMID 36165795
Identifiers
NCT: NCT06537934 · PNRR-MCNT2- 2023-12377844