[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Scientific Institute San Raffaele\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":358},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,52,80,107,128,151,174,199,228,298,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100305417","dynamics-of-platelet-activation-in-patients-with-ventricular-assist-device-vad-100305417",false,"NCT03255928","Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)","Analysis of the Platelet Activity State in Patients Implanted With Ventricular Assist Device (VAD)","PASVAD","Inclusion Criteria:\n\n* All consenting patients candidates for short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device implantation\n* All consenting patients that are implanted with short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device\n\nExclusion Criteria:\n\n\\- Patients \\\u003C 18-years old",true,"ALL","18 Years","75 Years",{"count":22,"type":23},60,"ESTIMATED","2 Years","OBSERVATIONAL","Consenting patients with end-stage heart failure that are implanted with\u002Fcandidates for implant of a short-term\u002Fdurable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist Device (VAD) will be enrolled in the study.\n\nAim of the study is to evaluate the patients' haemostatic and coagulation profile, how it interacts with the support device as well as the effect of antithrombotic drugs. From these data, it will be possible to derive the mechanisms triggering post-implant thromboembolic\u002Fhemorrhagic complications and to identify potential therapeutic targets.",[28,29,30,31,32],"Thrombosis","Blood Coagulation Disorder","Platelet Thrombus","Platelet Dysfunction Due to Aspirin","Failure;Ventricular",[34,35,28,36,37,38],"Platelet activation","Ventricular Assist Device","Bleeding","Antithrombotic Pharmacological Therapy","Mechanical Circulatory Support","RECRUITING","2025-05-12",{"date":42,"type":43},"2025-05-15","ACTUAL",{"date":45,"type":43},"2017-06-29",{"date":47,"type":23},"2026-12-31",{"name":49,"class":50},"Scientific Institute San Raffaele","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":17,"sex":18,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":51},"100584463","geam-study-aims-at-assessing-the-role-of-genetic-testing-in-patients-with-arrhythmic-myocarditis-100584463","NCT06889662","GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis.","GEAM: Yield of GEnetic Testing in Arrhythmic Myocarditis","GEAM","Inclusion Criteria:\n\nPatients with ventricular arrhythmias (VA+) and without (VA-)\n\n* Diagnosis of myocarditis proven by EMB (ESC criteria) and\u002For CMR (updated Lake Louise criteria)\n* Age ≥ 10 years\n* Baseline ECG telemonitoring\n* Written informed consent Healthy controls\n* Provided a negative known history of myocarditis\n* The sample must have been biobanked as part of the study IMMUNORADAR\n\nExclusion Criteria:\n\nPatients with ventricular arrhythmias (VA+) and without (VA-)\n\n* Obstructive coronary artery disease, or lack of coronary angiography\u002Fcomputed tomography (CT) scan in patients \\>40 years.\n* Absent informed consent.","10 Years","80 Years",{"count":63,"type":23},262,"This study aims to answer multiple unsolved questions in the field of arrhythmic myocarditis.\n\n* Improving the diagnostic work-up. While endomyocardial biopsy (EMB) and cardiac magnetic resonance (CMR) constitute the gold standard diagnostic techniques for myocarditis, the role of genetic testing is still unclear. Identifying the subset of patients with CGVs, will contribute to justifying the application of genetic testing in myocarditis.\n* Generating models for risk prediction. Outcomes and arrhythmic risk stratification remain uncertain for myocarditis. Based on an advanced multimodal work-up, multiparametric risk scores may be created and subsequently validated, in order to predict the arrhythmic risk of specific myocarditis, especially in the case of CGVs.\n* Identifying disease-specific and genotype-specific signatures. Genotype-phenotype associations are expected to benefit from a multimodal and multiparametric approach, in order to allow etiology-specific features in arrhythmic myocarditis. Most of the current signatures are limited to combined EMB-CMR studies. Signatures would likely benefit from implementing additional parameters, including arrhythmia features and myocardial inflammatory status.\n* Tailoring treatment strategies. Transcriptional analysis will identify overexpressed genes associated with myocarditis and arrhythmias, representing a possible therapeutic target. A multimodal and multidisciplinary model will integrate phenotype, genotype, and transcriptional profile for a personalized treatment.",[66,67],"Myocarditis","Ventricular Arrythmia",[69,70,71],"Arrhythmogenic cardiomyopathy","Ventricular arrhythmias","Myocardial inflammation","2025-03-19",{"date":74,"type":43},"2025-03-21",{"date":76,"type":43},"2025-02-25",{"date":78,"type":23},"2027-12-01",{"name":49,"class":50},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100572733","multicenter-analysis-of-different-approaches-in-segmentectomies-in-early-stage-lung-cancer-100572733","NCT06737107","Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer","Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach","ANASEGME","Inclusion Criteria:\n\n* Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.\n* Age \\> then 18 years at the moment of surgery\n\nExclusion Criteria:\n\n* Age \\\u003C then 18 years at the moment of surgery\n* diagnosis other than NSCLC",{"count":89,"type":23},472,"The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.",[92,93],"Early Stage Lung Cancer (I and II)","Non-Small Cell Lung Cancer",[95,96,97],"Video-Assisted Thoracoscopic Surgery","open approach","Robot-Assisted Thoracoscopic Surgery","2024-12-11",{"date":100,"type":43},"2024-12-17",{"date":102,"type":43},"2024-11-26",{"date":104,"type":23},"2026-05-31",{"name":49,"class":50},4,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100564212","analysis-of-rats-vats-and-open-lung-resections-after-neoadjuvant-chemo-immunotherapy-in-patients-performed-in-five-referred-centers-100564212","NCT06626243","Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers","An International Multicenter Retrospective Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy","IMMUNORATS","Inclusion Criteria:\n\n* Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024\n* Received neoadjuvant chemo-immunotherapy or immunotherapy alone\n* Age \\>= 18 years old at the moment of surgery\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old at the moment of surgery",{"count":116,"type":23},140,"The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.\n\nThere are no risks for the patients, as this is a retrospective data collection.",[93],[95,97,96],{"date":121,"type":43},"2024-11-29",{"date":123,"type":43},"2024-09-30",{"date":125,"type":23},"2025-10-15",{"name":49,"class":50},6,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100554230","robotic-assisted-major-lung-resection-in-elderly-patients-100554230","NCT06496386","Robotic Assisted Major Lung Resection in Elderly Patients","Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study","ELDERLY","Inclusion Criteria:\n\n* Age \\>18 years at the moment of surgery\n* Suspected or confirmed diagnosis of lung cancer\n* The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable\n* Absence of extrapulmonary metastases that are not controlled or controllable\n* All procedures included use of DaVinci robot system\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years at the moment of surgery\n* Patients who cannot undergo surgery, as they do not meet the conditions outlined above",{"count":137,"type":23},386,"The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.\n\nThere are no risks for the patients, as this is a retrospective data collection.",[140],"Lung Cancer",[142,143],"robot-assisted thoracoscopic surgery","lung resection",{"date":145,"type":43},"2024-11-27",{"date":123,"type":43},{"date":148,"type":23},"2026-10-31",{"name":49,"class":50},2,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":51},"100552247","the-lymphocytic-infiltrate-of-lung-tumors-100552247","NCT06470607","The Lymphocytic Infiltrate of Lung Tumors.","Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors","TREGILC","Inclusion Criteria:\n\n* Ability to provide informed consent;\n* Men and women over the age of 18;\n* Patients candidates for surgical treatment diagnosed with thoracic tumors\n\nExclusion Criteria:\n\n* Previous chemotherapy for any cancer within the last 6 months;\n* Pregnant and\u002For breastfeeding women;\n* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive\u002Fimmunomodulatory treatments)",{"count":160,"type":23},70,"The study is configured as a monocentric observational transversal biological study.\n\nThe main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC).\n\nThe study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.",[140,163],"Immune System",[165,166,167],"thoracic tumors","Immune checkpoints","lymphocytes",{"date":121,"type":43},{"date":170,"type":43},"2023-01-20",{"date":172,"type":23},"2028-01-31",{"name":49,"class":50},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":18,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":51},"100550742","prevention-of-smoking-related-diseases-100550742","NCT06451029","Prevention of Smoking Related Diseases","Integrated Primary and Secondary Prevention of Smoking Related Diseases With Low Dose CT Scan and Circulating Biomarkers, Coupled With Personalised Smoking Cessation Activity","LSP-3","Inclusion Criteria:\n\n* Strong smokers (pack years \\>= 20)\n* Over or equal the age of 50\n* Able to sign specific informed consent for the study\n\nExclusion Criteria:\n\n* Not having plans to quit smoking","50 Years",{"count":184,"type":23},189,"This is a prospective, observational, monocentric study. This study wants to test if among a smoking cessation intervention, behavioural counselling by video session is related to higher compliance and higher success rate than standard smoking cessation activity (face to face counselling).",[140,187,188],"Lung Cancer Screening","Smoking Cessation",[190,191,192],"lung cancer screening","smoking cessation","counseling",{"date":121,"type":43},{"date":195,"type":43},"2022-01-11",{"date":197,"type":23},"2025-12-31",{"name":49,"class":50},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":51},"100564207","development-of-an-artificial-intelligence-model-for-the-identification-and-prevention-of-smoking-related-diseases-100564207","NCT06626178","Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.","ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases","ARIA","High-risk screening subjects\n\nInclusion Criteria:\n\n* Age \\>= 50 years old\n* Active smokers\n* Former smokers (from no more than 15 years)\n* Pack\u002Fyear \\>20\n* Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) \\>1.2%\n* Provision and signature of informed consent\n\nExclusion Criteria:\n\n* Previous or concurrent neoplastic disease, excluding skin cancers\n* Cognitive or other problems that could hinder the collection of informed consent\n* Severe pulmonary or extra pulmonary disease\n* Previous low-dose computed tomography (CT) scan in the past 12 months\n\nPrevious high-risk positive screening subjects\n\nInclusion Criteria:\n\n* Subjects enrolled in previous lung cancer screening with the presence of lung nodules \\>4 mm and candidate to additional computed tomography (CT)\n* Signed informed consent\n\nExclusion Criteria:\n\n\\- None\n\nPrevious high-risk negative screening subjects\n\nInclusion Criteria:\n\n* Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)\n* Signed informed consent\n\nExclusion Criteria:\n\n\\- None\n\nLung Cancer patients\n\nInclusion Criteria:\n\n* Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it\n* Patients with diagnosis of lung cancer treated with surgical resection\n* Signed informed consent\n\nExclusion Criteria:\n\n* computed tomography (CT) scans not available at San Raffaele Hospital\n* Previous neoadjuvant treatment",{"count":208,"type":23},2840,"INTERVENTIONAL",[211],"NA","The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.",[214,215],"Lung Cancer Screening Program","Artificial Intelligence (AI)",[217,218,219,220],"CT scan low-dose","Artificial Intelligence","High-risk sucjects","Lung cancer","2024-10-01",{"date":223,"type":43},"2024-10-03",{"date":221,"type":43},{"date":226,"type":23},"2028-11-01",{"name":49,"class":50},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":235,"targetDuration":237,"studyType":25,"phases":4,"briefSummary":238,"conditions":239,"keywords":255,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":51},"100562769","multimodal-and-multidisciplinary-approach-to-optimize-diagnostic-prognostic-and-therapeutic-management-of-patients-with-non-ischemic-cardiomyopathies-and-arrhythmogenic-inflammatory-phenotypes-a-multicenter-observational-retrospective-and-prospective-registry-study-100562769","NCT06607471","Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.","AINICM","Inclusion Criteria:\n\n* Written informed consent. For pediatric patients, consent will be obtained by parents, according to the laws applicable in each of the participating countries.\n* Clinical suspicion of NICM, and\u002For proven diagnosis of any NICM and\u002For genotype consistent with any NICM.\n\nNICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic\u002Fautoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge.\n\nExclusion Criteria:\n\n* Absent informed consent.\n* Proven diagnosis of cardiac disease alternative to NICM.\n* Lack of diagnostic workup suitable for diagnosing NICM, detecting arrhythmias, or detecting M-Infl.\n* For patients retrospectively enrolled: lack of active status of follow-up at the enrolling center.",{"count":236,"type":23},15000,"30 Years","Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the myocardium. The main identified forms include dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy (RCM), and arrhythmogenic cardiomyopathy proper (ACM). More recently, further forms of cardiomyopathy have been described, less common and not uniquely classifiable, including: uncompressed myocardium (LVNC), peripartum cardiomyopathy (PPCM), structural correlates of arrhythmogenic mitral valve prolapse (AMVP), Anderson-Fabry disease (AFD), NICM associated with multi- system neuromuscular or autoimmune diseases, lysosomal diseases, glycogenosis, mitochondrial cytopathies and canal diseases with structural substrates. Finally, there are \"overlap\" forms, characterized by the sharing in the same subject of characteristic aspects of two or more of the above- mentioned diseases; and of the \"undefined\" forms, which to date do not reach the diagnostic criteria for any of the above-mentioned diseases.\n\nTo the best of current knowledge, there are two points discovered in scientific research, namely the description of the arrhythmogenic and \"inflammatory\" phenotypes in a broad sense, which are summarized here with the acronym AINICM. In detail:\n\n1. Arrhythmic manifestations account for the arrhythmogenic component of AINICM, which is not limited to ACM proper. In fact, most of the above diseases have a non-arrhythmic clinical presentation and a prevailing tendency to evolve towards a picture of cardiovascular decompensation. Although sudden arrhythmic death has been described throughout the spectrum of AINICM, early arrhythmic manifestations of such diseases have an unknown prevalence, an uncertain association with different disease genotypes and phenotypes, and still uncertain predictivity of long-term arrhythmic risk. At the same time, optimal diagnostic and therapeutic pathways in arrhythmias associated with AINICM are still being studied.\n2. Myocardial inflammation (M-Infl) accounts for the inflammatory component of AINICM, and has recently been described in association with many AINICM on a genetic basis, including undefined and arrhythmic forms. The data is of high interest not only in the diagnostic, but also in prognostic and therapeutic field. In fact, on the one hand the presence of M-Infl seems to have a physio- pathological role in AINICM; on the other, as already known in myocarditis, the optimal therapeutic paths of arrhythmias may differ in patients with and without M-Infl; in particular, also in the light of the preliminary data available in adult and paediatric AINICM, the inflammatory forms are expected to respond better to immunosuppressive therapy, the arrhythmogenic ones to an ablative therapy with frequent need of implantation of cardiac devices.\n\nBased on the clinical presentation, NICM patients will be divided into arrhythmic (AINICM) and non-arrhythmic patients as study and control groups , respectively. The AINICM group will include presentation with ventricular fibrillation (VF), either sustained or non-sustained ventricular tachycardia (VT; NSVT), frequent premature ventricular complexes (PVC), supraventricular arrhythmias (SVA) and bradyarrhythmias (BA). Clinical presentations other than arrhythmic, including chest pain and heart failure, will define the control group. In parallel, as shown in Figure 1, patients with any evidence of M-Infl will be compared with those showing no signs of M-Infl.",[240,241,242,243,244,245,246,247,248,249,250,251,252,253,254],"Non-ischemic Cardiomyopathy","Dilated Cardiomyopathy (DCM)","Hypertrophic Cardiomyopathy (HCM)","Restrictive Cardiomyopathy","Arrhythmogenic Cardiomyopathy (AC, ARVD\u002FC)","Left Ventricular Noncompaction","Arrhythmogenic Mitral Valve Prolapse","Peripartum Cardiomyopathy","Anderson-Fabry Disease","Arrhythmic and Inflammatory Non-ischemic Cardiomyopathy","Inflammatory (Non-Arrhythmic) Non-ischemic Cardiomyopathy","Nonischemic Cardiomyopathy Sensu Strictu (Non-inflammatory, Non-arrhythmic)","Major Ventricular Arrhythmias, I.e. Sustained Ventricular Tachycardia, Ventricular Fibrillation, or Appropriate Therapy of Cardiac Device (defibrillators)","Overlapping Phenotype","Undefined Phenotypes",[69,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,71,280,281,282,283,284,285,286,70,287,288,289],"Adverse event","Anderson-Fabry disease","Arrhythmic and Inflammatory Non-ischemic cardiomyopathy","Arrhythmogenic mitral valve prolapse","Anti tachycardia pacing","Bradiarrhythmias","Cardiac magnetic resonance","Cardiac resynchronization therapy with defibrillator","Computed tomography","Development Safety Update Report","Ethics Committee","Electroanatomical map","Electrocardiogram","Endomyocardial biopsy","Good Clinical Practice","Hypertrophic cardiomyopathy","Implantable cardioverter defibrillator","Informed Consent Form","International Conference on Harmonization","Immunomodulatory therapy","Late gadolinium enhancement","Left ventricular ejection fraction","Left ventricular noncompaction","Last Visit of Last Subject","Non-ischemic cardiomyopathies","Positron emission tomography","Pacemaker","Peripartum cardiomyopathy","Premature ventricular complexes","Serious Adverse Event","Supraventricular arrhythmias","Ventricular fibrillation","Ventricular tachycardia (sustained)","sudden cardiac death","2024-09-18",{"date":292,"type":43},"2024-09-23",{"date":294,"type":43},"2018-01-30",{"date":296,"type":23},"2035-12-31",{"name":49,"class":50},{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":17,"sex":18,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":237,"studyType":25,"phases":4,"briefSummary":310,"conditions":311,"keywords":320,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":51},"100561522","role-of-endomyocardial-biopsy-and-aetiology-based-treatment-in-pediatric-patients-with-inflammatory-heart-disease-in-arrhythmic-and-non-arrhythmic-clinical-presentations-an-integrated-approach-for-the-optimal-diagnostic-and-therapeutic-management-myoped-100561522","NCT06591260","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management","MYOPED","Inclusion Criteria:\n\n* Written informed consent.\n* Age \\< 18 years.\n* Clinically suspected myocarditis.\n* Enrollment performed by one of the participating Centers.\n\nExclusion Criteria:\n\n* Absence of written informed consent.\n* Age \\> 18 years (adults)","0 Years","17 Years",{"count":309,"type":23},20,"Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.\n\nOptimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.\n\nBiomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.\n\nArrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.\n\nThe role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.\n\nUniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.",[66,312,313,314,315,316,317,318,319],"Ventricular Arrhythmia","Inflammatory Cardiomyopathy","Genetic Predisposition","Autoimmunity","Arrhythmia","Cardiomyopathies","Immunosuppresion","Catheter Ablation",[66,70,321,322,269,262,323,281,324,325,326,327,328,272,329,330],"Arrhythmias","Arrhythmogenic inflammatory cardiomyopathy","Ablation","Electroanatomical mapping","Immunosuppressive therapy","Arrhythmic risk stratification","Genetic predisposition","Environment","Implantable loop recorder","Multicenter","2024-09-11",{"date":333,"type":43},"2024-09-19",{"date":335,"type":43},"2013-01-01",{"date":337,"type":23},"2030-12-31",{"name":49,"class":50},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":346,"targetDuration":60,"studyType":25,"phases":4,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":356,"leadSponsor":357,"locationsCount":51},"100402555","role-of-endomyocardial-biopsy-and-aetiology-based-treatment-in-patients-with-inflammatory-heart-disease-in-arrhythmic-and-non-arrhythmic-clinical-presentations-an-integrated-approach-for-the-optimal-diagnostic-and-therapeutic-management-100402555","NCT04521790","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management","MYOCAR","Inclusion Criteria:\n\n* Written informed consent.\n* Age ≥ 18 years.\n* Clinically suspected myocarditis.\n* Enrollment performed by one of the participating Centers.\n\nExclusion Criteria:\n\n* Absence of written informed consent.\n* Age \\\u003C 18 years (paediatric population).",{"count":347,"type":23},1000,"Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.\n\n1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.\n2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.\n3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.\n4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.\n5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.",[66,67,313,314,315,316,317,350,319],"Immunosuppression",[66,70,321,322,269,262,323,281,352,324,325,326,327,328,272,329,330],"Cardiac imaging","2024-09-07",{"date":333,"type":43},{"date":294,"type":43},{"date":296,"type":23},{"name":49,"class":50},""]