[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione GISE Onlus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100552620","pilot-italian-cardiogenic-shock-initiative-100552620",false,"NCT06475456","Pilot Italian Cardiogenic Shock Initiative","SPOKE-HUB SHOCK PROTOCOL MANAGEMENT ACCORDING TO SCAI CLASS IN TURIN AND MILAN AREA","ICSI","Inclusion Criteria:\n\nAll subjects participating in this clinical trial must meet the following criteria:\n\nProspective cohort\n\n* For conscious patients, signed and dated informed consent and consent to the processing of personal data\n* For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18\n\nCS will be defined as:\n\n1. Systolic blood pressure (SBP) \\<90 mmHg or mean arterial pressure (MAP) \\<60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \\> 90 mmHg or MAP \\> 60 mmHg, OR need of MCS;\n2. At least one of the following criteria\u002Fsigns of overt hypoperfusion: mixed venous oxygen saturation \\<60%; arterial lactates \\> 2 mmol\u002FL; oliguria \\< 0.5 ml\u002FKg\u002Fh for at least 6 hours.\n3. CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)\n\nExclusion Criteria:\n\nPatients will be excluded if any of the following conditions apply:\n\n1. Cardiac arrest with no quantifiable or longer than 10 minutes \"no-flow\" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20')\n2. Absolute contraindication to support devices.\n3. CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning.\n4. Age greater than 75-year-old\n5. Life expectancy \\< 1 year due to other reason than cardiogenic shock.","ALL","18 Years","75 Years",{"count":21,"type":22},786,"ESTIMATED","30 Days","OBSERVATIONAL","Study Objective To evaluate the impact on 30-day mortality of the adoption of a dedicated cardiogenic shock protocol designed to improve communication and collaboration among centres to timely refer Cardiogenic Shock (CS) patients from spoke to hub centres in Turin and Milan metropolitan Area. Study Design A multicentre, observational, study, consisting of\n\n* retrospective cohort including anonymous data from electronic health records of patients admitted with acute myocardial infarction complicated by cardiogenic shock (AMICS) SCAI class B-D, from Jan 2016 until Dec 2019\n* prospective cohort including all consecutive patients admitted for AMICS SCAI class B-D in the study centres Study Population and Centres 768 patients admitted in spoke hospitals for AMICS: 384 in each study cohort. Four centres - two in Milan metropolitan Area and two in Turin - will serve as hub centres, each one receiving CS patients from three referring spoke centres. In total, 16 centres will be involved in the study. Follow-up period Up to 30 days from hospital admission Primary Endpoint The primary endpoint will be the short-term mortality defined as inhospital or 30-day mortality. Secondary Endpoints\n* In-hospital or 30-day incidence of:\n\n  1. stroke, (fatal or non-fatal) or TIA\n  2. bleedings (BARC classification ≥3),\n  3. renal replacement therapy (CVVH \u002F new onset of dialysis)\n  4. vascular complications (all complication needing intervention),\n  5. non-fatal myocardial infarction\n* Door-to-support time,\n* Onset of symptoms to support time Inclusion criteria Prospective cohort\n* For conscious patients, signed and dated informed consent and consent to the processing of personal data\n* For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve.\n* Aging more than 18 years\n* Patients admitted within 24h from the diagnosis of AMICS and SCAI SHOCK classification B to D.\n\nCS will be defined as:\n\n1. Systolic blood pressure (SBP) \\\u003C 90 mmHg or mean arterial pressure (MAP) \\\u003C 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \\> 90 mmHg or MAP \\> 60 mmHg, OR need of mechanical cardiac support (MCS);\n2. At least one of the following criteria\u002Fsigns of overt hypoperfusion: mixed venous oxygen saturation \\\u003C 60% arterial lactates \\> 2 mmol\u002FL; oliguria \\\u003C 0.5 ml\u002FKg\u002Fh for at least 6 hours.\n3. CS SCAI B-C-D following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHFCS) Exclusion criteria\n\n1\\) Cardiac arrest with no quantifiable or longer than 10 minutes \"no-flow\" time or with refractory cardiac arrest (defined as CPR lasting more than 20') 2) Absolute contraindication to mechanical circulatory support devices 3) CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning. 4) Age less than 18 years 5) Life expectancy \\\u003C 1 year due to other reason than cardiogenic shock. Study Timetable Retrospective data collection: Jan 2016 until Dec 2019 Date of first enrolment planned: September 2024 Duration of recruitment: 24 months Follow-up period: 30 days Statistical methods A sample size of 768 patients (384 in each arm) is required to provide the study an 80% power to detect superiority in the primary endpoint with an alpha error set at 0.05 and assuming 30-day mortality estimates of 48% in the pre-protocol group and 38% in group post protocol.",[27],"Cardiogenic Shock",[29,30],"cardiogenic shock","SPOKE-HUB","RECRUITING","2025-06-27",{"date":34,"type":35},"2025-07-01","ACTUAL",{"date":37,"type":35},"2024-12-01",{"date":39,"type":22},"2026-12-03",{"name":41,"class":42},"Fondazione GISE Onlus","OTHER",16,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":24,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100474252","gise-registry-of-transcatheter-treatment-of-mitral-valve-regurgitation-with-the-mitraclip-g4-100474252","NCT05455489","GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","Inclusion Criteria:\n\nSUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND\n\n* Left Ventricular End-Systolic Dimension \\\u003C70 mm\n* Mitral Valve area \\> 4 cmq\n* Left ventricular ejection fraction ≥20%\n* NYHA functional class II, III, ambulatory IV\n* brain natriuretic peptide BNP ≥300 pg\u002Fml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg\u002Fml and\u002For at least one hosp for HF (Heart failure) in the 12 months prior to enrollment\n* Age 18 years or older\n* Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF\n* Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND\n* Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device\n* MV area \\> 4 cm2\n* NYHA functional class \\> II\n* Age 18 years or older\n* Local HT decision In case of patients with a coexistence of both etiologies, they will be assigned to a subgroup based on the prevailing mechanism.\n\nTHE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from the criteria recommended by the American Society of Echocardiography 2003 Guidelines and based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR was 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them. For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on the integrative evaluation of multiple parameters recommended by the The American Society of Echocardiography (ASE)\n\nExclusion Criteria:\n\n* Significant right ventricular disfunction (TAPSE\\\u003C15 mm and\u002For S'\\\u003C8cm\u002Fs)\n* Systolic pulmonary artery \\> 70 mmHg with irreversible precapillary pulmonary hypertension\n* Severe TR Tricuspid valve regurgitation\n* Hemodynamic instability\u002FNYHA IV\n* Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia\n* Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies\n* CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days\n* Life expectancy \\\u003C12 months due to non-cardiac conditions\n* Active infections\n* Advanced HF (ESC\u002FHFA Heart Failure Association Criteria) or Bridge tp to HTx\u002FLVAD (left ventricular assist device)",{"count":52,"type":22},264,"5 Years","The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers (\"more-comers\") population with symptomatic severe mitral regurgitation undergoing\u002Fundergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.",[56],"Mitral Valve Regurgitation","2024-03-01",{"date":59,"type":35},"2024-03-04",{"date":61,"type":35},"2023-01-25",{"date":63,"type":22},"2029-08-01",{"name":41,"class":42},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":75,"studyType":24,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":65},"100474254","the-gise-societ-italiana-di-cardiologia-interventistica---shockcalcium-registry-100474254","NCT05455515","The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry","The GISE-ShockCalcium Registry - An Investigator Driven Italian All Comers Registry of Calcified Lesions Treated With Intravascular Lithotripsy","Inclusion Criteria:\n\n* Patients is ≥ 18 years of age.\n* Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who require an IVL with the Shockwave catheter.\n* Presence of single or multiple calcifications at the lesion site defined by,\n\n  a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section\n* Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life)\n* Ability to give written informed consent.\n* Patient is able and willing to comply with all follow-up assessments\n\nExclusion Criteria:\n\n* Refusal to participate in this study.\n* Calcific lesion within a \\> 4 mm reference segment of the vessel\n* Lesions in LIMA(left internal mammary artery)\u002FRIMA (rightinternal mammary artery) or at the distal anastomosis of an SVG (saphenous vein grafts)\n* All the usual relative contraindications to coronary angioplasty according to the clinical practice:\n* Patient has active systemic infection\n* Patient has a known untreated coagulation disorder\n* Patient has allergy to imaging contrast media for which he\u002Fshe cannot be pre-medicated\n* Patient is pregnant or nursing\n* Patients whose life expectancy is \\\u003C 1 year\n* Patients due to move abroad within 1 year",{"count":74,"type":22},2000,"1 Year","The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy. The main purpose is to evaluate the efficacy and safety of coronary lithotripsy for treatment of severe calcified lesion. A total of 2000 patients with coronary calcified lesions will be enrolled in 24 months. The registry will be conducted in approximately 50 interventional cardiology centers in Italy with at least 2 IVL procedures per 24 months. Primary endpoint: Target lesion failure (TLF) at 1 year.\n\nSecondary safety endpoints: in Hospital Target lesion failure (TLF); Target Lesion Failure at 30 days; definite or probable stent thrombosis; procedural angiographic safety endpoints. Secondary effectiveness endpoints: device crossing and IVL delivery success; angiographic success; QCA (quantitative coronary angiography) outcome; Imaging outcome.",[78],"Coronary Disease",{"date":59,"type":35},{"date":81,"type":35},"2022-09-17",{"date":83,"type":22},"2026-08-01",{"name":41,"class":42},""]