[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590602":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":48,"centralContacts":53,"locations":58,"responsibleParty":82,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",[8,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Ischemia with no obstructive coronary arteries (INOCA)",null,"Patients with suspected chronic coronary heart disease and non-obstructive coronary artery disease according to CT coronary angiography",[13,14,15,16,17],"Diagnostic Test: dynamic SPECT (two-day rest\u002Fstress protocol)","Diagnostic Test: gated myocardial perfusion imaging","Other: blood sampling","Diagnostic Test: Low Dose CT-scan","Diagnostic Test: CT-coronary angiography",{"label":19,"type":10,"description":20,"interventionNames":21},"Obstructive coronary artery disease (CAD)","Patients with chronic coronary heart disease and significant (\\>50%) lesion of one or more coronary artery according to CT coronary angiography",[13,14,15,16,17],{"label":23,"type":10,"description":24,"interventionNames":25},"Control","Patients without evidence of coronary heart disease",[13,14,15,16],[27,32,36,40,44],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DIAGNOSTIC_TEST","dynamic SPECT (two-day rest\u002Fstress protocol)","All nuclear examinations will be performed using a hybrid specialized SPECT\u002FCT Discovery NM\u002FCT570C. At the first stage the passage of the bolus of the radiopharmaceutical through the chambers and the LV myocardium will be recorded at rest. Through a pre-installed intravenous catheter, a bolus of the radiopharmaceutical in a volume of 5 ml (370 MBq) will be injected at a rate of 0,5 ml\u002Fsec, after which 30 ml of saline will be injected at a rate of 2 ml\u002Fsec. Data acquisition will begin immediately before the introduction of the radiopharmaceutical. Registration of dynamic images will be performed in the \"List Mode\".\n\nAt the second day stress test study will be performed (ATP at a dosage of 160 mcg\u002Fkg\u002Fmin over 4 minutes). The bolus volume of the radiopharmaceutical, saline and the rate are equal to the study at rest. The time of data collection at each stage of the study will be 12 minutes. The introduction of the radiopharmaceutical will be performed at 2 minutes of the stress test.",[23,9,19],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"gated myocardial perfusion imaging","Gated MPI will be performed according to a two-day rest-stress protocol. For both stress and rest studies, the acquisition will be performed 60 minutes after the dynamic SPECT. The recording time will be 5 minutes. To correct the attenuation, a low-dose CT scan of the chest, obtained earlier with dynamic recording, will be used. The voltage on the X-ray tube will be 120 kV, the current strength will be 20 mA; tube rotation time 0.8 s; pitch 0.969:1. Radiopharmaceutical administration will be performed only once a day during dynamic SPECT.\n\nImmediately after recording the gMPI at rest, the patient will undergo a series of sequential injections of dobutamine at doses of 5 and 10 µg\u002Fkg\u002Fmin with simultaneous recording. The duration of data collection on each dose of dobutamine will be 5 minutes.",[23,9,19],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"blood sampling","Indicators of:\n\n* endothelial dysfunction (specific endothelial cell molecule 1 (endocan, ESM1), endotelin-1)\n* severity of inflammatory response (tumor necrosis factor (TNF-α), interleukin-6 (IL-6))\n* myocardial fibrosis (matrix metalloproteinase (MMP-9)\n* myocardial dysfunction (NT-proBNP)",[23,9,19],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Low Dose CT-scan","Scanning parameters: tube voltage 120 kV; current 435 mA; tube rotation time 0.4 s; slice thickness 2.5 mm; interslice interval 2.5 mm.",[23,9,19],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"CT-coronary angiography","The study will be performed on a 64-slice GE Discovery NM\u002FCT 570С (GE Healthcare, Milwaukee, WI, USA) from the level of the tracheal bifurcation to the diaphragm during breath holding (6-8 s) in the prospective (for HR≤55) or retrospective (for HR\\>55) ECG-synchronized mode. To contrast coronary arteries, it is planned to use an intravenous infusion of 85-90 ml (at a rate of 5 ml\u002Fs) of an iodine-containing (370 mg iodine\u002Fml) radiopaque substance.Scan will be performed with the following parameters: current strength 120 kV; voltage 300-600 mA with ECG modulation; tube rotation speed 0.4 s; pitch: 0.18-0.22 (depending on heart rate).",[9,19],[49],{"name":50,"affiliation":51,"role":52},"Vladimir V Shipulin, MD, PhD","Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences","PRINCIPAL_INVESTIGATOR",[54],{"name":50,"role":55,"phone":56,"phoneExt":10,"email":57},"CONTACT","+79521575263","shipartphoto@gmail.com",[59],{"facility":60,"status":61,"city":62,"state":10,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Tomsk NRMC Cardiology Research Institute","RECRUITING","Tomsk","634012","Russia","RU",{"type":67,"coordinates":68},"Point",[69,70],84.98216,56.50049,{"lat":70,"lon":69},[73,77,79],{"name":74,"role":55,"phone":75,"phoneExt":10,"email":76},"Nina J. Anfinogenova, PhD","+7 (3822) 55-41-11","cardio.intl@gmail.com",{"name":78,"role":52,"phone":10,"phoneExt":10,"email":10},"Vladimir V. Shipulin, PhD",{"name":80,"role":81,"phone":10,"phoneExt":10,"email":10},"Stepan A. Kunitsin","SUB_INVESTIGATOR",{"type":52,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Vladimir Shipulin","Dr.",[86],{"name":87,"class":6},"Russian Science Foundation","100590602","mechanical-dyssynchrony-and-microvascular-dysfunction-by-spect-100590602",false,"NCT06969547","Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT","Evaluation the Capabilities of Cardiac Mechanical Dyssynchrony in the Diagnosis of Myocardial Microvascular Dysfunction in Chronic Ischemic Heart Disease","MD&MD","Inclusion Criteria:\n\n* Ischemia with no obstructive coronary arteries (INOCA)\n* Obstructive coronary artery disease (CAD)\n* Patients without evidence of coronary heart disease\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction \\\u003C55% according to echocardiography;\n* History of myocardial infarction\u002Frevascularization;\n* hypertension: systolic blood pressure \\>180 mm Hg. Art., diastolic BP\\>110 mm Hg. Art.;\n* systolic arterial hypotension \\\u003C80 mm Hg. Art.;\n* atrial fibrillation;\n* AV blockade of the III degree; sick sinus syndrome;\n* massive pulmonary embolism (PE) with a high degree of pulmonary hypertension;\n* the presence of significant valvular pathology (mitral insufficiency ≥ 3 degrees, aortic insufficiency ≥ 3 degrees, tricuspid regurgitation ≥ 3 degrees).\n* severe course of bronchial asthma, chronic obstructive pulmonary disease;\n* decompensated type 2 diabetes,\n* severe liver or kidney failure (glomerular filtration rate \\\u003C50 ml\u002Fmin\u002F1.73 m3 (CKD-EPI),\n* morbid obesity (body mass index \\>45);\n* history of myocarditis\n* indications of poor drug tolerance;\n* oncological diseases;\n* chronic alcoholism, mental disorders;\n* other severe comorbidity,\n* refusal to participate in the study.",true,"ALL","18 Years","75 Years",{"count":101,"type":102},75,"ESTIMATED","OBSERVATIONAL","The project is aimed at studying the feasibility of mechanical dyssynchrony of the left ventricle of the heart, determined by SPECT (gated MPI), as well as its stress-induced dynamics, in the evaluation of patients with coronary microvascular dysfunction in chronic coronary heart diseasу.",[106,107,108],"Myocardial Blood Flow Reserve","Mechanical Dyssynchrony","Coronary Arterial Disease (CAD)",[110,111,112,113,114],"SPECT","gated MPI","mechanical dyssynchrony","dobutamine","myocardial bloow flow reserve","2025-09-22",{"date":117,"type":118},"2025-09-24","ACTUAL",{"date":120,"type":118},"2023-10-01",{"date":122,"type":102},"2026-05-15",{"name":5,"class":6},1]