[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"John Paul II Hospital, Krakow\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":179},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,71,96,123,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100531656","hypotension-prediction-index-hpi-in-lung-resections-100531656",false,"NCT06202638","Hypotension Prediction Index (HPI) in Lung Resections","An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status II to IV;\n* Planned invasive blood pressure monitoring during general anesthesia expected to last more than 2 hours and planned overnight hospitalization.\n* Procedures: video-assist thoracoscopic (VATS)-lobectomy, open-thoracotomy lobectomy, pneumonectomy.\n* Adults over 18 years old.\n\nExclusion Criteria:\n\n* Urgent\u002Femergency procedures.\n* Patients with known clinically important intracardiac shunts.\n* Moderate to severe valvular disease.\n* Preoperative symptomatic arrhythmias including AF.\n* Congestive heart failure with LV ejection fraction less than 35%.\n* Refusal of participation","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","1 Day","OBSERVATIONAL","Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.",[25],"Intraoperative Hypotension",[27,28,29,30],"Hypotension","One Lung Ventilation","Intelligence","Artificial","RECRUITING","2025-08-07",{"date":34,"type":35},"2025-08-12","ACTUAL",{"date":37,"type":35},"2023-11-11",{"date":39,"type":20},"2025-12-31",{"name":41,"class":42},"John Paul II Hospital, Krakow","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100478289","phase-3-the-effect-of-sacubitrilvalsartan-versus-ramipril-on-left-ventricular-function-and-remodeling-in-patients-with-ischemic-heart-failure-with-mid-range-ejection-fraction-100478289","NCT05508035","The Effect of Sacubitril\u002Fvalsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction","CRACOVIA-HF","Inclusion Criteria:\n\n* Written consent to participate in the study, expressed prior to any procedures related to the study.\n* Age 18 and over.\n* Symptomatic HF in NYHA class II to IV of ischemic etiology.\n* Left ventricular ejection fraction at screening visit ranged from 40-49%.\n* Elevated concentration of NT-proBNP natriuretic peptide ≥125 pg\u002Fml.\n* Features of a structural \u002F functional disease of the left ventricle.\n* Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated.\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.\n* Previous history of intolerance to recommended ACEI or ARB target doses.\n* Known history of angioedema.\n* Requirement of simultaneous treatment with ACEI and ARB.\n* Acute decompensated HF within 6 weeks prior to screening visit.\n* Symptomatic hypotension systolic blood pressure \\\u003C100 mmHg at screening visit.\n* Current or previous treatment with sacubitril \u002F valsartan.\n* Estimated creatinine clearance \\\u003C30 ml \u002F min \u002F 1.73 m2 at screening visit.\n* Serum potassium \\>5.2 mmol \u002F L at screening visit.\n* Acute coronary syndrome or elective revascularization within 6 weeks prior to screening.\n* Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening.\n* Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI.\n* Fixed atrial fibrillation.",{"count":52,"type":20},666,"INTERVENTIONAL",[55],"PHASE3","Heart failure with moderately reduced ejection fraction (HFmrEF) is a frequent disease associated with significant morbidity and mortality and therefore requires effective therapies that may improve clinical outcomes. The most common reason of HFmrEF is ischemic injury, usually caused by myocardial infarction, that may lead to left ventricular remodeling and systolic dysfunction, accompanied by symptoms of heart failure. Therefore, the anti-remodeling therapies may effectively improve clinical outcomes. Recently, sacubitril\u002Fvalsartan - the angiotensin receptor neprilysin inhibitor suppressing the renin-angiotensin-aldosterone system and enhancing the effect of natriuretic peptides - has been introduced in the treatment of heart failure. To date, this drug was found to be clinically beneficial in patients with heart failure with reduced ejection fraction (HFrEF), however has not been tested in the group of patients with HFmrEF.\n\nThe aim of the study is to evaluate effectiveness of sacubitril\u002Fvalsartan as compared with ramipril on left ventricular remodeling and function in patients with ischemic HFmrEF.\n\nPatients with ischemic HFmrEF, New York Heart Association class II-IV symptoms, an elevated plasma natriuretic peptide level and the left ventricular ejection fraction (LVEF) of 40-49 % will be enrolled in this prospective, multicenter, randomized, double-blind, active-controlled study. Initially, patients will enter a single-blind ramipril run-in period (titrated to 5 mg bid), followed by a sacubitril\u002Fvalsartan run-in period (100 mg titrated to 200 mg bid). A total of 666 patients tolerating both periods will be randomized 1:1 to either ramipril 10 mg bid or sacubitril\u002Fvalsartan 200 mg bid. The primary endpoint will be the change of left ventricular end-systolic volume index within 12-month of treatment as measured by magnetic resonance imaging. The main secondary endpoints include the change of left ventricular end-diastolic volume index within 12-month of treatment, the change of LVEF within 12-month of treatment, 12-month composite endpoint of cardiovascular death or heart failure requiring hospitalization, 12-month cardiovascular death, 12-month heart failure requiring hospitalization, time to death or heart failure requiring hospitalization or mortality rate within 12-month of treatment.\n\nThis study may determine the place of sacubitril\u002Fvalsartan as an alternative to ramipril in the treatment of patients with ischemic HFmrEF in order to prevent further left ventricular remodeling and to improve its systolic function.",[58],"Heart Failure with Moderately Reduced Ejection Fraction",[60,61],"chronic heart failure","congestive heart failure","2024-10-29",{"date":64,"type":35},"2024-10-31",{"date":66,"type":35},"2023-07-13",{"date":68,"type":20},"2027-06",{"name":41,"class":42},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":53,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":70},"100383313","micronet-covered-stent-system-for-stroke-prevention-in-all-comer-carotid-revascularization-100383313","NCT04271033","MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization","Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND","PARADIGM-EXT","General Inclusion Criteria:\n\n* Patient \\> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care\n* Signed informed consent\n* Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.\n\nAngiographic Inclusion Criteria:\n\n* De-novo atherosclerotic lesions or neo-atherosclerosis\n* Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or\n* Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method\n\nGeneral Exclusion Criteria:\n\n* Lack of NeuroVascular Team agreement on carotid revascularization indication\n* Lack of signed informed consent\n* Estimated life expectancy less than 1 year\n* Chronic renal failure with serum creatinine level \\> 3.0 mg\u002FdL\n* Myocardial Infarction within 72 hours prior to index procedure.\n* Pregnant women\n* Diagnosed coagulopathies\n* History of contrast media allergy, not reacting to pharmacotherapy\n\nAngiographic Exclusion Criteria:\n\n* Index lesion occlusion\n* Common carotid artery stent protruding to aortic arch\n* Anatomical conditions restricting stent implantation\n* Significant common carotid artery stenosis proximal to index lesion (unless treated)",{"count":80,"type":20},550,[82],"NA","All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.",[85],"Carotid Artery Diseases",[87],"Stenting","2022-03-14",{"date":90,"type":35},"2022-03-29",{"date":92,"type":35},"2015-09-01",{"date":94,"type":20},"2026-06",{"name":41,"class":42},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":70},"100454293","acute-stroke-of-carotid-artery-bifurcation-origin-treated-with-use-of-the-micronet-covered-cguard-safeguard-stroke-100454293","NCT05195658","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)","Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF The MicronEt-covered CGUARD STent Under TRansient FlOw Reversal LinKed With Thrombus REtrieval: SAFEGUARD-STROKE Study","Inclusion Criteria:\n\n* Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis\u002Focclusion as culprit lesion.\n* Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.\n* Patient eligible for endovascular stroke therapy according to AHA\u002FASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.\n* Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)\n* Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.\n\nExclusion Criteria:\n\n* Known stroke cause other than the carotid bifurcation lesion\n* Lack of effective endovascular route needed for intervention\n* Any known contraindications to stroke endovascular management",{"count":104,"type":20},20,"Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use.\n\nA study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and\u002For cerebral tissue window allowing guideline-indicated reperfusion by interventional management.\n\nA registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.",[107,108],"Carotid Artery Stenosis","Acute Ischemic Stroke",[110,108,111,112,113,114],"Carotid Stenosis","Anesthesia","Imaging","Interventional Management","Thrombectomy","2022-02-23",{"date":117,"type":35},"2022-02-28",{"date":119,"type":35},"2022-01-30",{"date":121,"type":20},"2027-12-31",{"name":41,"class":42},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":70},"100458494","transcranial-doppler-cerebral-blood-flow-and-cognitive-impairment-in-heart-failure-100458494","NCT05250349","TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure","TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence\u002FAbsence of Atherosclerotic Carotid Artery Stenosis","TRACE-IMPAIR","Inclusion Criteria:\n\n* Clinically stable patients (NYHA I-III symptoms) with HF (for at least 6 months) either of ischemic or inflammatory etiology as well as genetic cardiomyopathies\n* Signed informed consent form\n* Consent to imaging studies: echocardiography, carotid and transcranial Doppler sonography and neuropsychological tests (MMSE and MoCA).\n\nExclusion Criteria:\n\n* Co-existing, severe, irreversible disease (e.g. advanced cancer)\n* Previously diagnosed dementia (including severe dementia - MMSE and MoCA score \\\u003C10)\n* Psychiatric condition which may influence cognitive function\n* Acute, decompensated HF\n* Reversible cause of HF - tachyarrhytmic, peripartum or toxic cardiomyopathy, acute myocarditis, acute myocardial infarction\n* Aortic stenosis\n* Cerebral stroke in the preceding 3 months\n* Lack of transcranial Doppler acoustic window\n* Echocardiographic projections precluding adequate measurements\n* Anemia with Hemoglobin \\\u003C 8 g\u002Fdl\n* Alcohol or psychoactive agents abuse",{"count":132,"type":20},300,"TRACE-IMPAIR is a prospective, clinical study of consecutive patients that evaluates the relationship between heart failure (HF) and cognitive impairment in relation to carotid and cerebral flow. The carotid and cerebral flow will be assessed using Doppler ultrasonography, and cognitive function will be estimated during routine neuropsychological tests.\n\nIt is an observational, three(natural)-group, single-center study. It is also an Academic Registry - the scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University, and John Paul II Hospital.",[135,136,110],"Heart Failure","Cognitive Impairment",[110,135,138,139,140,136,141],"Carotid Doppler","Transcranial Doppler","Cerebral Flow","Stroke Volume","2022-02-10",{"date":144,"type":35},"2022-02-22",{"date":146,"type":35},"2021-09-01",{"date":148,"type":20},"2027-09-01",{"name":41,"class":42},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":70},"100437231","simultaneous-cardiac-surgery-and-micronet-covered-stent-carotid-revascularization-in-high-perioperative-stroke-risk-patients-100437231","NCT04973579","Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients","SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study","SIM-GUARD","Inclusion Criteria:\n\n* Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.\n* Signed informed consent form\n* Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up\n* De novo atherosclerotic lesions or neo-atherosclerosis.\n* Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or\n* Asymptomatic patients with carotid artery stenosis ≥70-80% as assessed by angiography (NASCET method).\n* Coronary angiography-confirmed multivessel disease or left main stem stenosis with the symptoms of unstable angina or non-ST-segment elevation myocardial infarction.\n* Severe symptomatic valvular disease detected by echocardiography.\n\nExclusion Criteria:\n\n* Expected survival time \\\u003C1 year (e.g., cancer).\n* Renal failure with GFR \\\u003C 20 ml\u002Fmin\u002F1.73 m2 as calculated by the CKD-EPI formula\n* Women who are pregnant (pregnancy test).\n* Coagulopathies.\n* History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.\n* Total carotid artery occlusion.\n* Stent in the carotid artery that protrudes into the aortic arch.\n* Anatomic variants that preclude stent implantation.\n* Significant stenosis of the common carotid artery proximal to the target lesion.\n* Mobile atherosclerotic plaques in the aortic arch.\n* Anatomy of the coronary arteries unsuitable for bypass grafting.\n* Lack of available vascular material for grafting.\n* Porcelain aorta.",{"count":159,"type":20},50,"Prospective, single-center, clinical registry of patients with symptomatic\u002Fcritical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and\u002For severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and\u002For valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.\n\nAcademic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.",[110,162,163,164,165],"Coronary Artery Disease","Valvular Heart Disease","Myocardial Infarction","Pulmonary Edema With Heart Failure",[110,167,168,169,170],"Coronary Artery Disease, Valvular Disease","Heart Failure, Pulmonary Edema","Single Anesthesia","Simultaneous Procedure","2021-07-13",{"date":173,"type":35},"2021-07-22",{"date":175,"type":35},"2021-05-01",{"date":177,"type":20},"2027-05-01",{"name":41,"class":42},""]