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

NCT06537934 | Recruiting

• 1 other identifier: PNRR-MCNT2- 2023-12377844
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Interstitial Lung Diseases

Keywords

Cardiac fibrosis; Lung interstitial fibrosis

Outcome Measures

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

  months 2-12

Secondary Outcomes (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

  months 3-16

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

  months 19-24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.

  PMID: 30168753 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Palmisano A, Gnasso C, Cereda A, Vignale D, Leone R, Nicoletti V, Barbieri S, Toselli M, Giannini F, Loffi M, Patelli G, Monello A, Iannopollo G, Ippolito D, Mancini EM, Pontone G, Vignali L, Scarnecchia E, Iannaccone M, Baffoni L, Spernadio M, de Carlini CC, Sironi S, Rapezzi C, Esposito A. Chest CT opportunistic biomarkers for phenotyping high-risk COVID-19 patients: a retrospective multicentre study. Eur Radiol. 2023 Nov;33(11):7756-7768. doi: 10.1007/s00330-023-09702-0. Epub 2023 May 11.

  PMID: 37166497 BACKGROUND

• Pontone G, Baggiano A, Conte E, Teruzzi G, Cosentino N, Campodonico J, Rabbat MG, Assanelli E, Palmisano A, Esposito A, Trabattoni D. "Quadruple Rule-Out" With Computed Tomography in a COVID-19 Patient With Equivocal Acute Coronary Syndrome Presentation. JACC Cardiovasc Imaging. 2020 Aug;13(8):1854-1856. doi: 10.1016/j.jcmg.2020.04.012. Epub 2020 Apr 21. No abstract available.

  PMID: 32762888 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Anna Palmisano

CONTACT

0226436106; palmisano.anna@hsr.it

Antonio Esposito Esposito

CONTACT

0226436102; esposito.antonio@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: August 5, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Locations

IT (1)