[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centro Cardiologico Monzino\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":415},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,40,61,84,106,126,148,169,188,217,240,269,297,325,345,365,389],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100621426","transcatheter-mitral-and-tricuspid-interventions-a-cardiac-magnetic-resonance-study-100621426",false,"NCT07370467","Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study","TEMATIC-MR: Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study","TEMATIC-MR","Inclusion Criteria:\n\n* Age ≥ 18 anni\n* Signing informed consent\n* Patients who are candidates for transcatheter mitral or tricuspid surgery (TEER, TTVR).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Contraindications to CMR or administration of contrast medium (gadolinium)","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases. In recent years, the introduction of transcatheter techniques for valve repair and replacement (TVI) has revolutionised the treatment of these diseases, particularly for patients at high surgical risk or who are not candidates for traditional surgery. However, although these procedures are increasingly popular, their long-term effectiveness in terms of cardiac remodelling is still not well understood.\n\nCardiac magnetic resonance (CMR) techniques, with their advanced capabilities to provide anatomical and functional details of the heart, offer a unique opportunity to assess ventricular remodelling and valve function before and after transcatheter interventions. The ESC guidelines on valvulopathies published in 2021 recommend the use of cardiac magnetic resonance imaging not only to quantify the extent of mitral and tricuspid regurgitation when echocardiography is inconclusive, but also as the gold standard for the assessment of left and right ventricular size and function (limited, however, to the availability of this method in the various centres). Currently, there are few systematic data evaluating the effect of these procedures on CMR-assessed cardiac anatomy and function. This study aims to fill this gap by creating a multicentre registry in which clinical and advanced imaging data, including 3D echocardiography and CMR, are collected to assess the impact of these therapies.\n\nAnalysis of data derived from advanced imaging will not only provide a better understanding of the mechanism of operation of transcatheter techniques, but will also provide important information for improving long-term patient outcomes by identifying potential predictors of treatment success or failure.",[25,26],"Mitral Insufficiency","Transcatheter Aortic Valve Replacement","RECRUITING","2026-06-08",{"date":30,"type":31},"2026-06-09","ACTUAL",{"date":33,"type":31},"2026-01-30",{"date":35,"type":21},"2026-09-30",{"name":37,"class":38},"Centro Cardiologico Monzino","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":39},"100639815","insights-from-the-fast-track-cabg-trial-a-clinical-outcome-study-in-patient-with-previous-surgical-revascularization-for-complex-three-vessel-or-left-main-coronary-artery-disease-based-on-coronary-computed-tomography-angiogram-and-fractional-flow-reserve-derived-by-computed-tomography-100639815","NCT07628270","Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography","FAST-CABG: Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, (CCTA) and Fractional Flow Reserve Derived by Computed Tomography (FFRCT)","FAST-CABG","Inclusion Criteria:\n\n* Patients who have analyzable pre-CABG CCTA imaging and received a successful CCTA-guided plus FFRCT CABG procedure.\n* Patient with known level of Lp(a) or with possibility to perform the test\n* Patent able to provide written informed consent as approved by the Ethical Committee\n\nExclusion Criteria:\n\n* Patients without pre-CABG CCTA imaging or those with who did not receive surgical revascularization.\n* Current treatment with lipoprotein apheresis\n* Patients who refuse to receive clinical follow-up\n* Unable to give Informed Consent",{"count":49,"type":21},100,"Coronary computed tomography angiography (CCTA) is a non-invasive imaging tool that characterizes coronary artery anatomy and provides detailed assessments of plaque morphology, composition , inflammation, and hemodynamics, which have crucial prognostic implications. The FASTTRACK CABG trial demonstrated that CCTA- fractional flow reserve derived from CCTA can plan and guide coronary artery bypass grafting treatment without traditional invasive coronary angiography and provides a valuable dataset of pre- and post-CABG CCTA for further research. This study is a sub-analysis of the FASTTRACK CABG trial and aims first of all to assess whether these imaging-derived markers can predict symptomatic relief and clinical outcomes for patients undergoing CABG, for complex three-vessel or left main coronary artery disease. Moreover, human coronary lesion studies from subjects with sudden death and carotid endarterectomy specimens demonstrate increasing levels of Lipoprotein(a) with lesion progression, peaking in ruptured plaques. Lp(a) is a low-density lipoprotein (LDL)-like particle comprising an apolipoprotein (apoB-100 molecule covalently linked to apo(a). Genome-wide association and Mendelian randomization studies provide strong evidence for the causal association between elevated Lp(a) levels and atherosclerotic cardiovascular diseases (ASCVD) risk. Current clinical guidelines, including the 2022 European Atherosclerosis Society (EAS) consensus, recommend measuring Lp(a) levels at least once in an adult's lifetime. Circulating Lp(a) levels remain relatively stable over a lifetime, making single measurements cost-effective for risk assessment. Established thresholds for high-risk Lp(a) levels are \\>50 mg\u002FdL or 125 nmol\u002FL, as recognized by assays standardized to WHO\u002FInternational Federation of Clinical Chemistry guidelines. Epidemiological data suggest that Lp(a) \\>30 mg\u002FdL increases the risk of coronary heart disease and myocardial infarction, while levels \\>50 mg\u002FdL elevate the risk of ischemic stroke. Approximately 20-25% of the general population has elevated serum Lp(a) levels. Despite robust evidence linking Lp(a) to ASCVD risk, data correlating Lp(a) levels with coronary artery calcium (CAC) progression remain limited. While Lp(a) and CAC independently predict ASCVD risk, their combined role in guiding prevention strategies is underexplored. Lipoprotein(a)-lowering strategies are currently being investigated in phase 3 cardiovascular outcomes trials. Specifically, the correlation between serum Lp(a) levels and CCTA-derived total calcified plaque volume has yet to be comprehensively studied.",[52],"Multivessel Coronary Artery Disease","2026-06-04",{"date":55,"type":31},"2026-06-05",{"date":57,"type":31},"2025-09-01",{"date":59,"type":21},"2026-05-31",{"name":37,"class":38},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100639969","natural-history-of-atrial-fibrillation-induced-tricuspid-valve-remodeling-in-the-absence-of-significant-tricuspid-regurgitation-a-three-dimensional-echocardiographic-study-100639969","NCT07617974","Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study","Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)","TRICUSPID-AF","Inclusion Criteria:\n\n* Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.\n\nEligible for enrollment in the control group will be:\n\n1. all consecutive patients with structurally normal hearts and no history of AF or;\n2. moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.\n\nExclusion Criteria:\n\n* Moderate or greater TR assessed using a multiparametric approach;\n* Arrhythmias other than AF;\n* Prior AF ablations;\n* Rapid ventricular response (average HR \\>110 bpm) during baseline TTE;\n* Inadequate image quality",true,{"count":71,"type":21},66,"This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.",[74,75],"Atrial Fibrillation (AF)","Tricuspid Regurgitation (TR)","2026-05-26",{"date":78,"type":31},"2026-06-01",{"date":80,"type":31},"2026-05-04",{"date":82,"type":21},"2027-05-31",{"name":37,"class":38},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100547647","trustworthy-integrated-artificial-intelligence-tools-for-predicting-high-risk-coronary-plaques-100547647","NCT06410690","Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS","Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS","AI-CORPS","Inclusion Criteria:\n\n* patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation;\n* CCTA performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices.\n\nExclusion Criteria:\n\n* performance of any non-invasive diagnostic test within 90 days before enrolment;\n* low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score;\n* acute coronary syndrome;\n* evidence of clinical instability;\n* contraindication to contrast agent administration and\u002For impaired renal function;\n* inability to sustain a breath hold;\n* pregnancy;\n* cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;\n* contraindications to the administration of sublingual nitrates, β-blockers or adenosine;\n* structural cardiomyopathy",{"count":93,"type":21},4000,"Coronary artery disease (CAD) is among the leading cause of death and disability. Identification of patients at high risk of cardiovascular events is pivotal. However, current risk stratification based on imaging and known biomarkers is suboptimal. The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD. The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (CCTA) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. Finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (CTP-PRO study) to assess the robustness and accuracy of the proposed solution.",[96,97],"Coronary Artery Disease","Coronary Computed Tomography Angiography",{"date":99,"type":31},"2026-05-29",{"date":101,"type":31},"2023-05-22",{"date":103,"type":21},"2026-11-30",{"name":37,"class":38},2,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":39},"100639190","mitral-valve-calcium-assessment-with-truevue-trans-illumination-3d-rendering-100639190","NCT07612553","MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.","MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).","MAC-SEE","Inclusion Criteria\n\nRetrospective Cohort\n\n* Have already undergone, between February 2025 and September 2025, a contrast-enhanced CT scan and a transesophageal echocardiogram.\n* Are ≥ 18 years old.\n\nProspective Cohort\n\n* Are scheduled to undergo a contrast-enhanced CT scan and a three-dimensional transesophageal echocardiogram as part of their routine clinical assessment for their underlying cardiac condition, with or without mitral annular or leaflet calcifications.\n* Are ≥ 18 years old\n* who have provided written informed consent to participate in the study\n\nExclusion Criteria:\n\nRetrospective Cohort\n\n* The following patients will be considered not eligible:\n* Patients younger than 18 years.\n* Patients whose data are incomplete for the purposes of the planned study assessments\n* Patients who have explicitly refused the use of their data for research purposes.\n\nProspective Cohort\n\n* Patients younger than 18 years.\n* Patients who have not signed the study Informed Consent Form",{"count":49,"type":21},"The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures. Computed tomography (CT) is the non-invasive imaging modality considered the gold standard for the assessment of mitral valve calcifications, thanks to its high spatial resolution and the strong X-ray attenuation of calcium deposits.\n\nEchocardiography has traditionally played a limited role in the evaluation of mitral valve calcifications, particularly with three-dimensional imaging. Three-dimensional transesophageal echocardiographic rendering with TrueVue transillumination (Philips Medical Systems, Eindhoven, NL) can provide additional information on the location and extent of calcium on the mitral valve by allowing the placement of a virtual light source beneath the mitral valve.\n\nSpecifically, the TrueVue system is an advanced software module integrated into Philips echographic equipment that uses data acquired by the transesophageal probe to generate photorealistic images of the heart.\n\nTherefore, the ability to evaluate the position and extent of calcifications through transesophageal echocardiography may represent an important step forward for echocardiographic imaging.",[117,118],"Mitral Annular Calcification","Mitral Valve Disease","2026-05-21",{"date":121,"type":31},"2026-05-28",{"date":123,"type":31},"2025-12-17",{"date":78,"type":21},{"name":37,"class":38},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":22,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100640653","validation-of-the-italian-schfi-v8-and-the-cc-schfi-v3-100640653","NCT07608393","Validation of the Italian SCHFI v.8 and the CC-SCHFI v.3","Validation of the Italian Version of the Self-care of Heart Failure Index (SCHFI) v.8 and the Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) v.3","Inclusion Criteria for patients:\n\n* Ability to understand and speak Italian\n* Willingness to firm the informed consent form\n* Heart Failure for at least 3 months\n* Aged \\>\u002F= 18 years old\n\nInclusion Criteria for caregivers:\n\n* Ability to speak and understand Italian\n* Being selected as principal caregiver by the patient\n* Aged \\>\u002F= 18 years old\n\nExclusion Criteria:\n\n* cognitive impairment\n* surgery or heart attack in the last 3 months\n* having a LVAD",{"count":134,"type":21},1000,"3 Weeks","This observational study aims at validating the Italian Self-care of Heart Failure Index (SCHFI) v.8 and the Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) v.3",[138],"Heart Failure","NOT_YET_RECRUITING","2026-05-19",{"date":142,"type":31},"2026-05-27",{"date":144,"type":21},"2026-05",{"date":146,"type":21},"2027-05",{"name":37,"class":38},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":39},"100542022","computational-modelling-of-myocardial-perfusion-to-improve-outcome-prediction-based-on-coronary-artery-stenosis-and-atherosclerotic-plaque-burden-assessment-by-computed-tomography-100542022","NCT06337461","Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography","CONCERTO","Inclusion Criteria:\n\n* Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography.\n\nExclusion Criteria:\n\n* Low pre-test likelihood of CAD\n* Prior myocardial infarction\n* Previous history of revascularization\n* Acute coronary syndrome\n* Need for an emergent procedure\n* Evidence of clinical instability\n* Contraindication for contrast agent or impaired renal function\n* Inability to sustain a breath-hold\n* Pregnancy\n* Atrial fibrillation or flutter\n* BMI \\> 35kg\u002Fm2\n* Presence of pm or ICD\n* Contraindications to the administration of sublingual nitrates, betablockade, and adenosine",{"count":156,"type":21},400,"Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \\[Computational method for simulating myocardial blood flow in stress conditions\\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).\n\nOn top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques.",[159],"Chronic Coronary Syndrome",[161,162],"CT Perfusion","Myocardial Blood Flow",{"date":164,"type":31},"2026-02-03",{"date":101,"type":31},{"date":167,"type":21},"2026-05-30",{"name":37,"class":38},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":39},"100542307","multiparametric-scores-for-prediction-of-myocardial-fibrosis-in-patients-with-mitral-valve-prolapse-100542307","NCT06341166","Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse","Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial","SCIMITAR","Inclusion Criteria:\n\n* age ≥ 18 years\n* Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views\n\nExclusion Criteria:\n\n* age\\\u003C 18 years\n* coexistence of other cardiomyopathies or other ≥ moderate valve diseases\n* scarce acoustic transthoracic echocardiographic window\n* usual contraindications for cardiac magnetic resonance",{"count":178,"type":21},300,"This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.",[181],"Mitral Valve Prolapse",{"date":164,"type":31},{"date":184,"type":31},"2023-06-19",{"date":186,"type":21},"2026-06-19",{"name":37,"class":38},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":216},"100587023","phase-2-statin-effect-on-arrhythmogenic-cardiomyopathy-disease-progression-search-100587023","NCT06922994","Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)","Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression","SEARCH","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age, at the time of signing the informed consent\n2. Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria\n\nExclusion Criteria:\n\n1. Known hypersensitivity to atorvastatin or any of the excipients\n2. Moderate or severe liver disease\n3. Muscle disease\n4. Left ventricular ejection fraction \\\u003C35%\n5. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.\n6. Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities\n7. Hypercholesterolemic patients that require the use of lipid lowering drugs.\n8. Heart transplantation\n9. Estimated life expectancy of less than 2 years\n10. Any other medical condition that, in the judgment of the investigator, places the patient at risk or makes the patient unreliable or limits the patient's ability to complete the study\n11. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol\n12. Fusidic acid (drug for bacterial infections)\n13. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir\u002Fpibrentasvir and ledipasvir\u002Fsofosbuvir combination\n14. Any other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants , PCSK9 inhibitors, Adenosine triphosphate-citrate lyase inhibitors , Fibrates, Omega-3 fatty acid ethyl esters\n15. Drugs primary indicated as antioxidants\n16. Enrollment in another clinical trial or past clinical trial in which an investigational drug was administered within 30 days of Visit 1 or within the 5 half-lives of the investigational drug, whichever is longer.\n17. Pregnant or lactating women\n18. Women of childbearing age who are not using adequate contraception\n19. Known dependency on alcohol - drug abuse.\n20. Contraindications to cardiac magnetic resonance",{"count":197,"type":21},102,"INTERVENTIONAL",[200],"PHASE2","The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy. It will also learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are:\n\n1. Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?\n2. Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?\n3. What medical problems do participants have when taking Atorvastatin 80 mg?\n\nResearchers will compare Atorvastatin 80 mg to a placebo (a look-alike substance that contains no drug) to see if the drug works to treat Arrhythmogenic Cardiomyopathy.\n\nParticipants will:\n\n1. Take Atorvastatin 80 mg or a placebo every day for 18 months;\n2. Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;\n3. Make a phone call for safety check after 12, 15 and 19 months since the enrollment;\n4. Fill out psychological questionnaires",[203],"Arrhythmogenic Cardiomyopathy",[205,206,207,208],"Atorvastatin","Strain","Disease progression risk","Arrhythmias","2025-07-02",{"date":211,"type":31},"2025-07-03",{"date":213,"type":31},"2025-03-31",{"date":103,"type":21},{"name":37,"class":38},5,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":226,"studyType":22,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":39},"100594410","incidence-of-late-haemorrhage-after-invasive-gastroenterological-endoscopic-manoeuvre-in-patients-treated-with-anticoagulants-compared-to-non-anticoagulated-patients-100594410","NCT07019077","Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients","EMOSCOPIO","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Expected endoscopic manoeuvre among those listed below\n* EGDS ± biopsy\u002Fpolypectomy\n* Colonoscopy ± biopsy\u002Fpolypectomy\n* Echoguided endoscopy ± biopsy\u002Fpolypectomy\n* Double-balloon enteroscopy\n* ERCP (endoscopic retrograde cholangio-pancreatography) ± sphincterotomy\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Known active neoplasms of the gastroenteric tract\n* Gastrointestinal procedures performed as an emergency\n* Patients with an intrinsic haemorrhagic diathesis (e.g. known plateletopenia \\\u003C 50,000\u002Fmmc)\n* Patients on antiplatelet treatment with clopidogrel or other thienopyridines",{"count":225,"type":21},4719,"30 Days","Patients on oral anticoagulant therapy with vitamin K antagonists (AVKs; warfarin and acenocoumarol) and direct oral anticoagulants (DOACs; apixaban, dabigatran, edoxaban and rivaroxaban), are advised to consider discontinuing treatment in anticipation of invasive manoeuvres. Guidelines and expert consensus recommend, in clinical conditions with a high risk of bleeding, to suspend oral anticoagulant treatment with DOACs 2 or 3 days before the procedure, depending on the glomerular filtrate, to suspend warfarin from day -5 and acenocoumarol from day -4, and to introduce heparins from day -3 after discontinuation of AVKs (so-called 'bridging therapy') for manoeuvres with a high risk of bleeding. In manoeuvres with a low bleeding risk it is possible not to suspend the anticoagulant or to reduce its intensity. Obviously, the patient's intrinsic haemorrhagic and thrombotic risk (antiplatelet intake, renal insufficiency, hepatopathy, age, mechanical valve prosthesis, oncological condition, etc.) must also be taken into account in the overall assessment of pre-procedural preparation.\n\nGastroenterological endoscopic manoeuvres are generally considered to be at low haemorrhagic risk even if biopsy is planned, but are at high haemorrhagic risk if polypectomy or mucosectomy is planned. The most complex problem arises at the time of re-introduction of anticoagulant post-procedure. In fact, studies evaluating this specific aspect are very few and heterogeneous and mostly retrospective. The variables that are associated with an increased risk of bleeding are: the number and site of polypectomies, the diameter of the polyps, and local haemostasis techniques. Late haemorrhages (\\>24 hours) are of concern because the patient is generally at home and because, by the time the eschar falls out (varying between 4 and 10 days post-procedure), they have already resumed anticoagulation. However, there are no prospective studies of sufficient number to clarify whether the reintroduction of anticoagulation modifies the haemorrhagic risk, when is the time of greatest risk after the procedure, and which variables associated with the patient and the procedure most modify the haemorrhagic risk.",[229],"Bleeding",[231],"endoscopic gastroenterological manoeuvre","2025-06-05",{"date":234,"type":31},"2025-06-13",{"date":236,"type":31},"2025-05-19",{"date":238,"type":21},"2027-06-30",{"name":37,"class":38},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":69,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":198,"phases":249,"briefSummary":251,"conditions":252,"keywords":256,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":39},"100582016","infection-control-link-nurses-program-to-improve-compliance-with-standard-precautions-hand-hygiene-and-prevent-healthcare-associated-infections-100582016","NCT06857825","Infection Control Link Nurses Program to Improve Compliance With Standard Precautions, Hand Hygiene, and Prevent Healthcare-Associated Infections","Effectiveness of Implementing an Infection Control Link Nurses Program to Improve Nurses' Compliance With Standard Precautions, Healthcare Professionals' Compliance With Hand Hygiene, and to Prevent Healthcare-Associated Infections: a Cluster Randomized Controlled Trial","INFECTION","Inclusion Criteria:\n\n* Nursing staff working full time in the hospital wards and intensive care units partecipating in the study\n\nExclusion Criteria:\n\n* Nurses unavailable to sign informed consent",{"count":49,"type":21},[250],"NA","The goal of this clinical trial is to learn if Infection Control Link Nurses (i.e., clinical nurses providing direct patient care with an interest and expertise in infection control practices) are effective in improving nurses' compliance with standard precaution measures, healthcare professional's compliance with hand hygiene practices and in reducing healthcare-associated infections. The main questions it aims to answer are:\n\n* Are Infection Control Link Nurses effective in improving nurses' compliance with standard precautions?\n* Are Infection Control Link Nurses effective in improving healthcare professionals' compliance with hand hygiene practices?\n* Are Infection Control Link Nurses effective in improving alcohol-based hand rub consumption?\n* Are Infection Control Link Nurses effective in reducing healthcare-associated infections? In this study, a total of 8 hospital units will be randomized in two groups: 1) Intervention group, where in 4 hospital units will be selected and trained 4 Infection Control Link Nurses; and 2) Control group, where in 4 hospital units will continue usual IPC practice.\n\nTraining of Infection Control Link Nurses will be 12 months-long, with regular monthly scheduled meetings.\n\nResearchers will compare Intervention group with the Control group to see if nurses' compliance with standard precautions and healthcare professionals' compliance with hand hygiene will improve in the Intervention group, and if overall healthcare-associated infection incidence will decrease.\n\nParticipants will be nurses working full time in the selected hospital units, for a total of 100 nurses. They will sign an Informed Consent form and they will fill out a validated instrument named \"Compliance with Standard Precautions Scale-Italian Version\", to measure their adherence to standard precautions measures (i.e., use of protective device, disposal of sharp, disposal of waste etc). Concurrently, evaluation of healthcare professionals' compliance with hand hygiene will be done via direct observation, following World Health Organization's Technical Manual, by hospital staff who did not participate in the conception and design of the study. Lastly, data regarding alcohol-based hand rub consumption and healthcare-associated infections will be collected by experienced personnel who routinely perform these activities. The study will last 12 months, data collection will be carried out at baseline (pre-implementation of infection control link nurses) and after 12 months (after infection control link nurses implementation).",[253,254,255],"Standard Precautions","Hand Hygiene Behavior","Healthcare Associated Infections",[257,258,259,253,260],"Infection Control Link Nurse","Nursing","Hand Hygiene","Healthcare-associated infections","2025-04-03",{"date":263,"type":31},"2025-04-04",{"date":265,"type":31},"2025-03-20",{"date":267,"type":21},"2026-08",{"name":37,"class":38},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":22,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100584076","metabolic-exercise-test-data-combined-with-cardiac-and-kidney-indexes-mecki-score-evolution-identification-of-cardiovascular-risk-in-patients-with-heart-failure-100584076","NCT06884631","Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure","Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure","MECKI","Inclusion Criteria:\n\n* age \\>18 past or present heart failure (NYHA functional class I-III, stage C of the ACC\u002FAHA classification)\n* documentation of left ventricular systolic dysfunction (LVEF \\\u003C40%)\n* stable clinical conditions\n* previous or concomitant cardiopulmonary exercise test\n\nExclusion Criteria:\n\n* scheduled cardiovascular treatment\n* clinical unstable condition\n* History of pulmonary embolism, significant valvular disease, pericardial disease, severe COPD, exercise-induced angina, exercise-induced ECG changes, severe brady- or tachyarrhythmias, or the presence of comorbidities that interfere with exercise performance.",{"count":278,"type":21},10000,"10 Years","Heart failure is a complex condition involving multiple organs beyond the cardiovascular system, all influencing disease progression and prognosis. Accurate risk assessment requires considering multiple variables, as no single parameter alone provides a complete prognostic picture.\n\nThis has led to the development of prognostic models combining clinical and laboratory parameters. Some of these models incorporate cardiopulmonary exercise testing (CPET), which provides key prognostic indicators. Since the 1990s, CPET has been recommended in heart failure management guidelines due to its strong prognostic value when combined with clinical data.\n\nHowever, existing risk models often exclude important predictors such as ventilatory parameters from CPET (VE\u002FVCO₂), renal function, and hemoglobin levels. To address this gap, in 2012 the investigators developed the MECKI (Metabolic Exercise test data combined with Cardiac and Kidney Indexes) score, integrating oxygen consumption, ventilatory efficiency, and easily accessible biochemical and echocardiographic parameters. Unlike previous models requiring extensive data collection, MECKI is based on only six variables, making it practical and effective.\n\nRecent studies suggest the need to update the cutoff values and parameters used for risk stratification, as new therapies and treatment strategies may significantly alter prognostic accuracy in different patient populations.\n\nThis study aims to expand and refine the MECKI score by updating the patient dataset, optimizing its performance in specific subgroups, and aligning it with emerging therapeutic approaches.\n\nAdditionally, the investigators will evaluate whether the model's risk accuracy varies in advanced-stage patients, those with comorbidities, or under different treatment regimens. This could lead to correction factors that enhance the score's predictive power across diverse clinical scenarios, further improving its applicability and reliability in heart failure management.",[138],[283,284,285,286,287],"prognosis","risk score","heart failure","cardiopulmonary exercise test","exercise","2025-03-18",{"date":290,"type":31},"2025-03-19",{"date":292,"type":31},"2021-02-10",{"date":294,"type":21},"2028-12-31",{"name":37,"class":38},26,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":198,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":105},"100572777","the-effects-of-body-scan-on-enteroception-in-patients-with-heart-failure-100572777","NCT06737679","The Effects of Body Scan on Enteroception in Patients With Heart Failure","The Effects of Body Scan on Enteroception in Patients With Heart Failure: a Randomized Controlled Trial","SCAN-HF","Inclusion Criteria:\n\n* Diagnosed with Heart Failure\n* Italian speaking\n* Willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Cognitive Impairment documented in the medical records","75 Years",{"count":307,"type":21},110,[250],"The study aims to explore the effects of body scan on enteroception in people with heart failure",[138],[312,313,314,315,316],"Heart failure","Enteroception","Body scan","Mindfullness","Self-care monitoring","2025-02-05",{"date":319,"type":31},"2025-02-07",{"date":321,"type":31},"2025-01-28",{"date":323,"type":21},"2026-01-31",{"name":37,"class":38},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":344,"locationsCount":39},"100577513","mecki-amyloidosis-assessment-of-the-exercise-capacity-and-prognosis-of-patients-with-cardiac-amyloidosis-100577513","NCT06799273","MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis","MECKI-AMI","Inclusion criteria\n\n* Age \\> 18 years\n* Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy\n* Ability to perform a cardiopulmonary exercise test\n\nExclusion criteria\n\n* severe obstructive pulmonary disease\n* exercise-induced angina\n* significant ECG changes\n* presence of clinical comorbidities that interfere with exercise performance","100 Years",{"count":334,"type":21},1400,"This study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. By conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis.\n\nOur study intends to follow patients for a period of two years, evaluating them every six months. This longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. Furthermore, it enables the development of a prognostic tool similar to the MECKI score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance.\n\nBy comparing our results with data from heart failure patients already included in the MECKI score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. Finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. By comparing our results with data from heart failure patients already included in the MECKI score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.",[337],"Cardiac Amyloidosis","2025-01-23",{"date":340,"type":31},"2025-01-29",{"date":342,"type":31},"2024-05-07",{"date":146,"type":21},{"name":37,"class":38},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":69,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":39},"100498352","measurement-of-cardiopulmonary-variables-after-acute-exposure-to-high-altitude-100498352","NCT05769140","Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude","Measurement of Cardiopulmonary Variables in a Large Group of Healthy Subjects with Acute Exposure to High Altitude","Inclusion Criteria:\n\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",{"count":353,"type":21},8000,"As altitude increases, the availability of oxygen in the air decreases, and just to compensate for this lack, the body increases cardiac and respiratory work and changes blood pressure. But that is not all: at altitude the body's ability to use oxygen is also limited. Thus, there is on one hand less oxygen available, and on the other a lower capacity to use it. All this generates significant alterations at the cardiovascular level, to the point of running possible risks of heart attack, stroke and acute pulmonary edema, particularly for individuals already suffering from cardiovascular disease.\n\nThe availability of modern cable cars allows an increasingly large number of individuals, including sedentary people, elderly subjects, and cardiorespiratory patients, to easily and rapidly reach high-altitude locations. Data on what happens on the cardiovascular system at high altitude are relatively scarce, and most experiments in the literature are limited by low sample sizes.\n\nThe primary purpose of this study is to assess the characteristics of a large population that acutely reached high altitude at Punta Helbronner (3,466 m above sea level), a location on Mont Blanc that is readily accessible by a 20-minute cableway ride from Courmayeur (Entreves station, 1,300 m, Skyway Monte Bianco). We aim to create a unique database and study correlations between altitude and cardiorespiratory parameters (heart rate, blood pressure, and Hb saturation) by collecting medical history data and biometric measurements in a very large population and to identify subjects most at risk of developing hypoxia at altitude. In a subset of subjects, differences in biometric variables after acute exposure at high altitude (in the transition between the downstream and the upstream measuring station) will be evaluated.\n\nTwo biometric multiparametric recording systems (Keito K9; Keito, Barcelona, Spain) were installed at Entreves station as well as at Punta Helbronner. Keito K9 is an automatic multiparametric recoding system for measuring peripheral oxygen saturation SpO2, heart rate HR (pulse oximeter), blood pressure (BP; wrist pressure cuff, automatic), height (laser height meter), weight (scale platform), and body mass index (BMI). Once initiated by the subject with the completion of a cardiology history questionnaire (self-reported), the automated Keito K9 system provides a sequence of vocal and animated directions to guide subjects through the measurements (the subject may elect to abstain from some of the measurements). Upon completion, the system prints a summary receipt for the subject, and the measurements are transmitted through a Wi-Fi network and collected in an Excel sheet.\n\nIt should be noted that all data collected will be anonymized or not traceable to the subject, through the use of a disposable identification card (for subjects who will perform both downstream and upstream measurement).",[356],"High Altitude Effects","2024-08-30",{"date":359,"type":31},"2024-09-04",{"date":361,"type":31},"2020-03-25",{"date":363,"type":21},"2026-12",{"name":37,"class":38},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":69,"sex":17,"minAge":372,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":39},"100539041","characterization-of-exosomes-platelets-released-100539041","NCT06298682","Characterization of Exosomes Platelets-released","EXOPLT","Inclusion Criteria:\n\n* subjects without known pathologies\n\nExclusion Criteria:\n\n* individuals with gastrointestinal diseases,\n* individuals with history of hepatic diseases,\n* individuals with history of urogenital diseases,\n* individuals with history of hematological diseases,\n* individuals with history of immunological diseases,\n* individuals with history of renal diseases,\n* individuals with history of metabolic diseases\n* individuals with history of respiratory diseases\n* individuals with history of cancer\n* individuals with history of cardiovascular disease\n* individuals having permanent organ damage\n* individuals with major trauma in the last 6 months prior to enrollment\n* individuals with surgery in the last 6 months prior to enrollment\n* individuals taking medication in the 15 days prior to enrolment.","20 Years","60 Years",{"count":375,"type":21},175,"Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.",[378],"Platelet Thrombus",[380],"exosomes, platelet activation, platelet inhibitors","2024-03-07",{"date":383,"type":31},"2024-03-12",{"date":385,"type":31},"2021-07-08",{"date":387,"type":21},"2027-07-07",{"name":37,"class":38},{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":198,"phases":399,"briefSummary":400,"conditions":401,"keywords":404,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":105},"100538416","cardiovascular-risk-assessment-in-a-cohort-of-italian-patients-with-type-1-diabetes-mellitus-cardt1-100538416","NCT06290544","Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1)","Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1","CARDT1","Inclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus.\n* Age ≥ 18 years.\n* Signed Informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy in progress.\n* Type 2 diabetes mellitus.\n* Secondary diabetes",{"count":398,"type":21},200,[250],"This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)\u002FEuropean Association for the Study of Diabetes (EASD) guidelines and \"The Steno Type 1 Risk Engine\" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.",[402,403],"Diabetes Mellitus, Type 1","Cardiovascular Diseases",[405,402,406,403],"Diabetes","Cardiovascular risk","2024-02-26",{"date":409,"type":31},"2024-03-04",{"date":411,"type":31},"2021-11-29",{"date":413,"type":21},"2026-07",{"name":37,"class":38},""]