[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559677":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":40,"locations":49,"responsibleParty":65,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracoronary hypothermia","EXPERIMENTAL","Selective intracoronary hypothermia starts by advancing the coronary guidewire beyond the occlusion of the culprit coronary vessel with subsequent over-the-wire balloon inflation at 5 atm at the site of the occlusion. Then, the guidewire is removed, and the infusion pump is connected to the over-the-wire balloon. Normal saline infusion starts with an infusion rate of 5 ml per minute and a duration of 5 minutes. The temperature of the saline is 4 °C. After that, the over-the-wire balloon is deflated, and infusion continues for 15 minutes at the same temperature and infusion rate of 5 mL per minute, followed by the standard percutaneous coronary intervention.",[13],"Procedure: Intracoronary hypothermia",{"label":15,"type":6,"description":16,"interventionNames":17},"Conventional percutaneous coronary intervention","The group will receive standard percutaneous coronary intervention.",[18],"Other: Standard percutaneous coronary intervention",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","This trial stands apart from other studies of intracoronary hypothermia, mainly because it will establish the role of intracoronary hypothermia in reducing infarct size not only in the left anterior descending artery territory but in other vessels as well, including the right coronary artery and circumflex coronary artery.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Standard percutaneous coronary intervention","Percutaneous coronary intervention is performed in a standard manner.",[15],[30,34,37],{"name":31,"affiliation":32,"role":33},"Christina Nasekina","Cardiology Research Institute, Tomsk National Research Medical Center","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":36},"Vyacheslav Ryabov","STUDY_DIRECTOR",{"name":38,"affiliation":32,"role":39},"Evgenyi Vyshlov","STUDY_CHAIR",[41,45],{"name":31,"role":42,"phone":43,"phoneExt":24,"email":44},"CONTACT","7-983-239-63-70","christina.nasekina@mail.ru",{"name":46,"role":42,"phone":47,"phoneExt":24,"email":48},"Yury Bogdanov","7-913-520-77-77","yury.bogdanov.md@gmail.com",[50],{"facility":32,"status":51,"city":52,"state":24,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Tomsk","634012","Russia","RU",{"type":57,"coordinates":58},"Point",[59,60],84.98216,56.50049,{"lat":60,"lon":59},[63,64],{"name":31,"role":42,"phone":43,"phoneExt":24,"email":44},{"name":46,"role":42,"phone":24,"phoneExt":24,"email":48},{"type":66,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100559677","intracoronary-hypothermia-as-a-prevention-of-reperfusion-injury-in-myocardial-infarction-100559677",false,"NCT06567249","Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.","Selective Intracoronary Hypothermia as a Prevention of Reperfusion Injury in ST-elevation Myocardial Infarction.","Inclusion Criteria:\n\n* Acute ST-elevation myocardial infarction\n* Time from onset of symptoms less than 12 hours\n* Given informed consent\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Cardiogenic shock\n* Conduction disturbance: Atrioventricular block: 2nd and 3rd degree. SA block.\n* Sick sinus syndrome requiring implantable pacemaker\n* Pulmonary edema\n* Active inflammatory condition\n* Active chemo\u002Fradiation therapy","ALL","18 Years","90 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Acute myocardial infarction with ST segment elevation is often accompanied by a totally occluded coronary artery. Which has deleterious effects on heart muscle. Primary percutaneous coronary intervention is the most effective mode of treatment for ST-elevation myocardial infarction (STEMI) patients. Despite the restoration of the blood flow, 30-60% of patients develop microvascular obstruction, which lowers the effects of the coronary blood flow restoration. The most advanced coronary microvascular obstruction presents as a no-reflow phenomenon, which is an abrupt deceleration or absence of coronary flow following stent implantation. Several pharmacological treatments have been proposed, as well as deferred stenting, but none of them really helped. Thus, new ways of alleviating coronary obstruction are warranted. One of the new ways of mitigating the reperfusion injury is intracoronary hypothermia, which showed to be safe on a handful of patients in small series. In the animal studies, intracoronary hypothermia demonstrated a protective effect in terms of reducing infarct area. But clinical studies failed to reproduce the protective effects of intracoronary hypothermia. Thus, our study, using a modified hypothermia protocol, will test the hypothermia hypothesis.",[85,86,87,88],"Myocardial Infarction","ST-Elevation Myocardial Infarction (STEMI)","Reperfusion Injury","Microvascular Occlusion",[90,91,92,93,94],"hypothermia","ST-elevation myocardial infarction","microvascular obstruction","reperfusion injury","STEMI","2025-12-08",{"date":97,"type":98},"2025-12-16","ACTUAL",{"date":100,"type":98},"2024-05-05",{"date":102,"type":79},"2026-12",{"name":5,"class":6},1]