Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-24 @ 7:00 PM
Study NCT ID:
NCT06537934
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac fibrosis', 'Lung interstitial fibrosis'], 'conditions': ['Interstitial Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '29773608', 'type': 'BACKGROUND', 'citation': "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': '30501130', 'type': 'BACKGROUND', 'citation': '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': '34760753', 'type': 'BACKGROUND', 'citation': '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': '26424523', 'type': 'BACKGROUND', 'citation': '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': '30168753', 'type': 'BACKGROUND', 'citation': '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': '37071165', 'type': 'BACKGROUND', 'citation': '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': '34874200', 'type': 'BACKGROUND', 'citation': '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': '36165795', 'type': 'BACKGROUND', 'citation': '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': '37166497', 'type': 'BACKGROUND', 'citation': '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': '32762888', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nAll 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 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.\n\nExclusion Criteria:\n\n* Subjects with active infectious disease;\n* known CAD;\n* history of previous percutaneous or surgical revascularization;\n* known cardiomyopathy;\n* previous heart failure;\n* presence of cardiac devices (prosthetic valve, ICD, PM, ICD-CRT, LVAD)\n* previous or active neoplasia;\n* pregnancy and breastfeeding;\n* allergy to iodine contrast agent;\n* claustrophobia;\n* glomerular filtration rate \\< 30mL/min\n* impossibility to lay down or breath old\n* absence of informed consent signed'}, 'identificationModule': {'nctId': 'NCT06537934', 'acronym': 'AMICI-ILD', 'briefTitle': 'Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases', 'orgStudyIdInfo': {'id': 'PNRR-MCNT2- 2023-12377844'}}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Palmisano Professor Anna Palmisano', 'role': 'CONTACT', 'email': 'palmisano.anna@hsr.it', 'phone': '0226436106'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Anna Palmisano', 'role': 'CONTACT', 'email': 'palmisano.anna@hsr.it', 'phone': '0226436106'}, {'name': 'Antonio Esposito Esposito', 'role': 'CONTACT', 'email': 'esposito.antonio@hsr.it', 'phone': '0226436102'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Palmisano', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}