[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":291},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,74,92,125,145,165,186,212,243,268],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100643015","phase-4-reperfusion-approach-in-predicted-in-hospital-delay-for-primary-pci-in-stemi-100643015",false,"NCT07641231","Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI","A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)","RAPID-STEMI","Inclusion Criteria:\n\n* Age equal or greater than 18 years\n* \"Symptom onset-randomization\" time interval \\\u003C12 hours\n* Predicted \"diagnosis-pPCI\" time interval equal or greater than 120 minutes\n* Predicted \"admission-pPCI\" time interval equal or greater than 60 minutes\n* Informed consent received\n\nExclusion Criteria:\n\n* Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and\u002For the inability to evaluate the study primary endpoint","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (\\>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.",[27],"STEMI - ST Elevation Myocardial Infarction",[29,30,31,32,33],"in-hospital fibrinolysis","STEMI","pharmacoinvasive strategy","myocardial infarction (MI)","thrombolysis","NOT_YET_RECRUITING","2026-06-08",{"date":37,"type":38},"2026-06-11","ACTUAL",{"date":40,"type":21},"2026-05-20",{"date":42,"type":21},"2029-05-20",{"name":44,"class":45},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100389155","registry-of-long-term-antithrombotic-therapy-1-100389155","NCT04347200","REGistry of Long-term AnTithrombotic TherApy-1","Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Chronic Coronary Syndromes","REGATTA-1","Inclusion Criteria:\n\n* coronary artery disease , confirmed by history of myocardial infarction, or revascularization, or definitive evidence of CAD on imaging\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to provide informed consent.\n* Acute coronary syndrome within 12 months before inclusion\n* Severe chronic heart failure (NYHA IV)\n* Stroke within 6 months before inclusion\n* Severe liver or muscle disease\n* Severe kidney disease \u002F renal failure with creatinine \\> 3 mg\u002Fdl\n* Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention -",{"count":56,"type":21},2000,"5 Years","OBSERVATIONAL","To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with chronic coronary syndromes",[61,62],"Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))","Peripheral Artery Disease",[64],"Coronary Artery Disease, Peripheral Artery Disease","RECRUITING","2026-04-27",{"date":68,"type":38},"2026-05-01",{"date":70,"type":38},"2015-01-15",{"date":72,"type":21},"2026-12-31",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":91,"locationsCount":46},"100389154","registry-of-long-term-antithrombotic-therapy-2-100389154","NCT04347187","REGistry of Long-term AnTithrombotic TherApy-2","Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Atrial Fibrillation","REGATTA-2","Inclusion Criteria:\n\n* Documented atrial fibrillation with CHA2DS2VASC \\> 1\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease \u002F renal failure with creatinine \\> 3 mg\u002Fdl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention",{"count":56,"type":21},"To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation",[85],"Atrial Fibrillation",[87],"atrial fibrillation, coronary artery disease",{"date":68,"type":38},{"date":70,"type":38},{"date":72,"type":21},{"name":44,"class":45},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":46},"100566461","phase-2-triple-combination-therapy-arni-sglt2i-mra-in-advanced-hfpef-100566461","NCT06655480","Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF","Effect on Clinical Status, Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy With a Sodium-glucose Cotransporter 2 Inhibitor, Angiotensin Receptor\u002FNeprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF","Inclusion Criteria:\n\n1. Signed and data informed consent;\n2. Symptoms and signs of HF;\n3. LV ejection fraction \\> 50%;\n4. NT-proBNP \\> 300 pg\u002FmL (for patients with atrial fibrillation NT-proBNP \\> 900 pg\u002FmL)\n5. LV diastolic dysfunction II-III grade OR\n\nLV diastolic dysfunction I grade and at least 2 out of 4:\n\n* Е\u002Fе' \\> 14\n* LAVi \\> 34 ml\u002Fm2 (for those with persistent atrial fibrillation \\> 40 ml\u002Fm2)\n* PASP \\> 35 mm Hg or TR velocity \\> 2.8 m\u002Fsec\n* LV mass index \\> 95 g\u002Fm2 for women \u002F \\> 115 g\u002Fm2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR\n\nChronic atrial fibrillation and at least 3 out of 4:\n\n* Е\u002Fе' \\> 11\n* E-wave velocity \\> 100 sm\u002Fs\n* TR velocity \\> 2.8 sm\u002Fs\n* DT ≤ 160 ms\n\nExclusion Criteria:\n\n1. Evidence of myocardial ischemia during stress echocardiography;\n2. Significant lesions of main coronary arteries;\n3. Atrial fibrillation with resting HR \\> 110 beats\u002Fmin;\n4. Continuous (\\>90 days) treatment with ARNI, SGLTi and\u002For AMR within 12 months prior to screening. The last administration of these drugs must be at least 30 days prior to randomization. Treatment with these drugs should not be interrupted for the purpose of inclusion in the study.\n5. Coronary bypass surgery, stroke or TIA within the last 3 months of screening;\n6. Myocardial infarction or myocardial revascularization within the last 3 months of screening;\n7. Systolic blood pressure \\\u003C 90 mmHg or ≥ 180 mmHg at screening or randomization;\n8. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);\n9. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;\n10. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;\n11. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);\n12. Primary pulmonary artery hypertension;\n13. Significant left sided structural valve disease;\n14. Anemia (Hb \\\u003C 100 g\u002FL);\n15. Obesity (body mass index \\> 50 kg\u002Fm2);\n16. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI);\n17. Impaired liver function (serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 × upper limit of normal);\n18. Addison's disease;\n19. Known hypersensitivity to medications used the in the study;\n20. Non-cardiac conditions that complicate\u002Fexclude participation in the study;\n21. Diseases associated with isolated LV insufficiency (idiopathic pulmonary hypertension, chronic thromboembolic pulmonary hypertension, etc.);\n22. Serum\u002Fplasma potassium \\>5.0 mmol\u002FL at screening or randomization or a history of hyperkalemia or acute renal failure during AMR treatment for \\>7 consecutive days leading to discontinuation of AMR treatment.\n23. For patients with diabetes mellitus:\n\n    * Type 1 diabetes mellitus;\n    * Presence of more than 4 episodes of moderate hypoglycemia within the past month or at least one episode of severe hypoglycemia within the past year;\n    * Glycated hemoglobin level \\> 9% or \\\u003C6%","40 Years","80 Years",{"count":102,"type":21},50,[104],"PHASE2","Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with \\[angiotensin receptor\u002Fneprilysin inhibitor \\[ARNI\\] + sodium-glucose cotransporter 2 inhibitor \\[SGLTi\\] + mineralocorticoid receptor antagonist \\[MRA\\]) or with individualized medical therapy \\[SGLTi + renin-angiotensin system inhibitor \\[RASi\\] \\[angiotensin receptor blocker \\[ARB\\] or angiotensin-converting enzyme inhibitor \\[ACE-I\\]), and will be treated for 52 weeks",[107,108,109],"HFpEF","LVDD","Myocardial Fibrosis",[107,111,112,113,114,115,116],"HF","left ventricular hypertrophy","diastolic dysfunction","cardiac reserves","LV filling pressures","myocardial fibrosis","2026-04-21",{"date":119,"type":38},"2026-04-24",{"date":121,"type":38},"2025-03-18",{"date":123,"type":21},"2027-12-31",{"name":44,"class":45},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":144,"locationsCount":46},"100580955","predictors-of-poor-prognosis-in-hfpef-100580955","NCT06844032","Predictors of Poor Prognosis in HFpEF","Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n1. Signed and data informed consent;\n2. New York Heart Association (NYHA) class II-III heart failure;\n3. Left ventricular ejection fraction \\> 50%;\n4. Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.\n\nExclusion Criteria:\n\n1. Evidence of myocardial ischemia during stress echocardiography;\n2. Significant lesions of the main coronary arteries;\n3. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);\n4. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;\n5. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);\n6. Primary pulmonary artery hypertension;\n7. Significant left-sided structural valve disease;\n8. Anemia (Hb \\\u003C 100 g\u002FL);\n9. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI);\n10. Non-cardiac conditions that complicate\u002Fexclude participation in the study;\n11. Exacerbation of heart failure less than 3 months prior to study entry.",{"count":133,"type":21},500,"Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.",[107],[107,111,113,137,112,114,116],"left ventricle (LV) filling pressures","2026-04-14",{"date":140,"type":38},"2026-04-17",{"date":142,"type":38},"2022-01-31",{"date":72,"type":21},{"name":44,"class":45},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":154,"studyType":58,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":46},"100568574","national-heart-failure-registry-100568574","NCT06683001","National Heart Failure Registry","CHaracterization Of the STate of the System of Care for Patients With Chronic Heart Failure in the Regions of the Russian Federation: Identification, Diagnostics, Treatment, Observation","Inclusion Criteria:\n\n* Any stage and\u002For any class of CHF\n\nExclusion Criteria:\n\n* Subjects whose source records cant be obtained for the analysis",{"count":153,"type":21},20000,"3 Years","A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation.\n\nThe study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination.\n\nA control observation group is not intended.",[157],"Chronic Heart Failure","2026-04-08",{"date":160,"type":38},"2026-04-13",{"date":162,"type":38},"2024-10-01",{"date":123,"type":21},{"name":44,"class":45},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":175,"studyType":58,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100374828","registry-of-arterial-hypertension-100374828","NCT04160533","Registry of Arterial Hypertension","Registry of Arterial Hypertension: \"Study of Modern Phenotypes of Arterial Hypertension, Including Secondary Forms, in Order to Create Personalized Methods of Treatment\"","Inclusion Criteria: The diagnosis of arterial hypertension -\n\nExclusion Criteria: No diagnosis of arterial hypertension\n\n\\-","99 Years",{"count":174,"type":21},10400,"1 Day","The problem of the quality of primary health care medical system for patients with arterial hypertension is acute for the investigator's country, as these diseases are the most common and cause the high mortality of the population.\n\nThe concept of \"quality of primary health care medical system\" includes its timeliness, accessibility and provision of medical care to the patient at the modern level, which is determined by the degree of performance by doctors of medical and diagnostic measures corresponding current clinical recommendations.\n\nThe system of cardiovascular desease registries, established in the Federal State Clinical Hospital of the Russian Federation Ministry of Public Health with the automated analysis of data on examination and treatment, in comparison with clinical Recommendations. It makes possibility to identify shortcomings and develop approaches to improving the provision of medical care to patients in real clinical practice.\n\nComparative analysis of the quality of examination and treatment in different samples of patients with cardiovascular desease, observed in 2018-2020, compared with results of previous years will identify ptrends in the provision of medical care to patients with cardiovascular desease.",[178],"Arterial Hypertension",{"date":160,"type":38},{"date":181,"type":38},"2018-06-01",{"date":183,"type":21},"2026-12",{"name":44,"class":45},17,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":46},"100627773","ultrasound-assisted-catheter-guided-thrombolysis-for-intermediate-high-risk-patients-with-pe-100627773","NCT07452991","ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE","ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With Pulmonary Embolism","ULTRA-PE","Inclusion Criteria:\n\n* Adults aged ≥ 18 years at time of enrollment;\n* Ability to provide written informed consent (or legally authorized representative consent where applicable);\n* Objectively confirmed acute pulmonary embolism (PE) by contrast-enhanced computed tomography pulmonary angiography (CTPA) demonstrating intraluminal filling defects in at least one segmental, lobar, or more proximal pulmonary artery;\n* Hemodynamically stable at presentation (i.e., not meeting high-risk PE criteria of sustained hypotension, shock, or need for vasopressor support per ESC 2019 and AHA\u002FACC risk stratification);\n* Evidence of right ventricular (RV) dysfunction on imaging (e.g., RV\u002FLV ratio \\> 1.0 on CTPA or echocardiography);\n* Elevated cardiac biomarkers, including troponin I or T above the upper limit of normal;\n* Intermediate-high risk features defined as the combination of imaging RV dysfunction and positive cardiac biomarkers, consistent with ESC stratification;\n* At least one clinical indicator of elevated early risk such as:\n\n  1. Tachycardia (e.g., HR ≥ 100 bpm),\n  2. Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds),\n  3. Hypoxemia (SpO₂ \\\u003C 90% on room air).\n\nExclusion Criteria:\n\n* Presence of hemodynamic instability, defined as at least one of the following:\n\n  1. Systolic blood pressure (SBP) \\\u003C 90 mmHg or a drop ≥ 40 mmHg from baseline for \\> 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis,\n  2. Requirement for vasopressors to maintain SBP ≥ 90 mmHg,\n  3. Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation),\n  4. Need for ECMO or other mechanical circulatory support initiated prior to assessment,\n  5. Cardiac arrest requiring resuscitation.\n* Active major bleeding or conditions with high bleeding risk (e.g., known intracranial pathology predisposed to hemorrhage or associated with ongoing pharmacotherapy);\n* Recent (\\\u003C 3 months) intracranial or intraspinal surgery, major trauma, or stroke;\n* Known central nervous system neoplasm or metastatic cancer with high bleed risk.\n* Administration of systemic thrombolytic agents or catheter-directed thrombolysis prior to registry assessment for the index PE episode;\n* Known hypersensitivity to alteplase, unfractionated heparin (UFH), or any of their excipients.\n* Requirement for intensive care admission for conditions unrelated to the index PE;\n* Duration of symptoms attributable to the index PE \\> 14 days at presentation, as defined in contemporary trial criteria;\n* Known severe thrombocytopenia (e.g., platelet count \\\u003C 100 × 10⁹\u002FL) or coagulopathy precluding safe catheter access;\n* Life expectancy \\\u003C 6 months due to advanced comorbid disease unrelated to acute PE;\n* Pregnancy.",{"count":195,"type":21},300,[197],"NA","Pulmonary embolism (PE) is a life-threatening condition and a leading cause of cardiovascular mortality. While systemic thrombolysis is the standard treatment for high-risk PE, its bleeding risk limits use in some patients, highlighting the need for alternative reperfusion strategies such as catheter-directed thrombolysis (CDT). This prospective study will evaluate the safety and efficacy of CDT using the EkoSonic Endovascular System (EKOS; Boston Scientific) in patients with intermediate-high and high-risk PE. The primary outcome is all-cause mortality through 360 days of follow-up, with secondary outcomes including changes in echocardiographic parameters such as the RV\u002FLV diameter ratio.",[200],"Pulmonary Embolism (PE)",[202,203],"Pulmonary embolism","Ultrasound-assisted Catheter-guided Thrombolysis","2026-03-13",{"date":206,"type":38},"2026-03-17",{"date":208,"type":38},"2024-09-10",{"date":210,"type":21},"2030-09-10",{"name":44,"class":45},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":231,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":46},"100604453","temporary-mcs-with-the-ivac-2l-transaortic-device-in-high-risk-pci-100604453","NCT07149714","Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI","Temporary Mechanical Circulatory Support With the iVAC 2L Transaortic Device in High-risk Percutaneous Coronary Intervention","POTOK","Inclusion Criteria:\n\n* Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an unusually high risk of periprocedural circulatory collapse.\n* Signed Informed Consent to participate in the study\n\nExclusion Criteria:\n\n* Femoral artery diameter \\\u003C 6.0mm\n* Significant biventricular or right heart failure\n* Thrombus in the left ventricle\n* Presence of a mechanical aortic valve\n* Aortic valve stenosis\u002Fcalcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic assessment graded as ≥+2)\n* Severe peripheral arterial disease precluding placement of the iVAC2L\n* Combined cardiorespiratory failure\n* Presence of an atrial or ventricular septal defect (including post infarct VSD)\n* Left ventricular rupture\n* Cardiac tamponade\n* Presence of any other subtype of shock\n* Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.)\n* Recent major bleeding event (\\\u003C 3 months)\n* Recent stroke (\\\u003C 3 months)",{"count":221,"type":21},100,[197],"Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention.\n\nThe transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve.\n\nThe pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole.\n\nThe primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.",[225,226,227,228,229,157,230],"Ischemic Cardiovascular Disease","Multivessel Coronary Artery Disease","Coronary Artery Disease","Cardiogenic Shock","Acute Heart Failure (AHF)","Percutaneous Coronary Intervention",[232,233,234],"Mechanical circulatory support","High-Risk Percutaneous Coronary Intervention","Coronary artery disease","2025-08-29",{"date":237,"type":38},"2025-09-08",{"date":239,"type":38},"2023-02-17",{"date":241,"type":21},"2029-02-17",{"name":44,"class":45},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":252,"targetDuration":254,"studyType":58,"phases":4,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":46},"100528123","russian-registry-of-endovascular-closure-of-pfo-100528123","NCT06156670","Russian Registry of Endovascular Closure of PFO","Russian Registry of Endovascular Closure of Patent Foramen Ovale","ENDOVAL","Inclusion Criteria:\n\n1. Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO;\n2. Presence of an open oval confirmed by ultrasound diagnostic methods;\n3. Age of patients from 18 years;\n4. Life expectancy of at least 1 year;\n5. Signed informed consent for endovascular closure of a PFO.\n\nExclusion Criteria:\n\n1. Inability to receive antiplatelet therapy;\n2. Presence of acute inflammatory diseases;\n3. Acute stage of cerebral circulatory failure (30 days);\n4. Myocardial infarction or aortocoronary bypass surgery within the previous 30 days;\n5. Carotid or vertebral artery dissection;\n6. Severe cardiac valve pathology;\n7. Presence of blood clots in the cardiac cavities;\n8. Refusal of the patient to participate in the study.","70 Years",{"count":253,"type":21},700,"12 Months","The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.",[257],"Patent Foramen Ovale",[257,259],"stroke","2025-01-27",{"date":262,"type":38},"2025-01-29",{"date":264,"type":38},"2023-12-01",{"date":266,"type":21},"2025-12-31",{"name":44,"class":45},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":46},"100545033","study-of-microvascular-dysfunction-cfr-and-cardioprotective-effect-of-early-administration-of-esmolol-in-mi-100545033","NCT06376630","Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI","Study of Microvascular Dysfunction, Coronary Flow Reserve and Cardioprotective Effect of Early Intravenously Administration of Esmolol in Patients With Myocardial Infarction","ESMO-VASCMI","Substudy evaluating cardioprotective effects of early iv administration of esmolol\n\nInclusion Criteria:\n\n* Diagnosed acute ST elevation MI, type 1, within the first 8 hours of disease onset;\n* Treating physician's decision not to administer metoprolol intravenously prior to primary PCI due to a high risk of complications (BP \\\u003C 120\u002F80 mm Hg at baseline examination, moderate evidence of heart failure (Killip 2) or a risk of its development (LV EF ≤ 30%), first degree AV block with PQ ≥ 0.25 ms, history of asthma or severe COPD etc.)\n* Signed Informed Consent to participate in the study\n\nExclusion Criteria:\n\n* severe heart failure (pulmonary edema; SCAI В-Е cardiogenic shock);\n* atrioventricular conduction abnormality higher than first degree, without a pacemaker;\n* sinus bradycardia with the heart rate of \\\u003C 60 bpm;\n* BP \\\u003C 100\u002F60 mm Hg.;\n* asthma in exacerbation;\n* history of a STEMI in the IRA basin;\n* clinically significant bleeding or hypovolemia;\n* hypersensitivity to esmolol;\n* pregnancy or lactation;\n* known severe comorbidities independently affecting prognosis (Child Pugh class C liver failure, active malignancies etc.);\n* contraindications to MRI (MR-incompatible pacemaker\u002Fimplanted cardioverter-defibrillator, cochlear implants, clips on brain vessels, foreign metal objects - bullets, intraorbital metal fragments, insulin pumps, body weight above 150 kg, history of allergies to gadolinium, claustrophobia);\n* severe dementia;\n* known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.);\n* complicated PCI, \"no reflow\" phenomenon on follow-up coronary angiography;\n* thrombolysis for AMI;\n* ECG evidence of spontaneous reperfusion on admission;\n* patient's refusal from participation in the study.\n\nSubstudy investigating coronary physiology\n\nInclusion Criteria:\n\n* Diagnosed MI, completed PCI for the IRA and multivessel Coronary Artery Disease with diameter stenosis of 50-85% in non-IRA.\n* Signed Informed Consent to participate in the study\n\nExclusion criteria:\n\n* History of coronary artery bypass grafting surgery;\n* Non-IRA lesions resulting in diameter stenosis of below 50% and above 85%, main left coronary artery (LCA) stenosis above 50%;\n* Chronic kidney disease stage 3b or above (glomerular filtration rate below 45 mL\u002Fmin\u002Fm2 according to the CKD-EPI equation);\n* History of a contrast-induced nephropathy (CIN) or a high CIN risk (calculated using the Mehran score);\n* History of allergies to iodine-containing medications;\n* Pregnancy or lactation;\n* Left ventricle ejection fraction ≤ 30%;\n* Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.);\n* Early post-infarction angina;\n* Severe dementia;\n* Patient's refusal from participation in the study.",{"count":195,"type":21},[197],"Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction.\n\nFirst substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement.\n\nSecond substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd\u002FPa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)\u002Fdt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection.\n\nPrimary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \\> 12 months post-infarction.\n\nSecondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement.",[280,281,282],"Myocardial Infarction","Coronary Stenosis","Coronary Microvascular Dysfunction","2024-04-18",{"date":285,"type":38},"2024-04-19",{"date":287,"type":38},"2024-01-29",{"date":289,"type":21},"2030-01-29",{"name":44,"class":45},""]