[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469495":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":18,"responsibleParty":35,"collaborators":37,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":18,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":65,"whyStopped":18,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":18},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront","ACTIVE_COMPARATOR","Immediately after restoration of distal flow, they will receive:\n\ni. Small dose Tirofiban (intra-coronary bolus of 25µg\u002FKg),\\[22\\] ii. Nitroglycerin 100-200 µg,\\[12\\] iii. Verapamil 100-200 µg (excluding patients with 2nd or 3rd degree AV block, bradycardia HR \\\u003C 60, or systolic BP \\\u003C100 mmHg)\\[5\\] iv. Two cycles of balloon up-balloon down (15 seconds occlusion, 15 seconds open artery; repeated two times).\n\nv. The rest of the procedure will be completed as standard practice.",[13],"Other: Upfront preparation of microcirculation to minimize risks of no-reflow and reperfusion injury",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","pPCI procedure will be performed as per standard practice.\\[2\\] Bail-out use of any pharmaceutical products will be allowed as per guidelines recommendations (such as: GPi in case of no-reflow or thrombotic complications).",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Upfront preparation of microcirculation to minimize risks of no-reflow and reperfusion injury","Tirofiban (intra-coronary bolus of 25µg\u002FKg) + Nitroglycerin (intracoronary 100-200 µg) + Verapamil (intracoronary 100-200 µg, yet excluding patients with 2nd or 3rd degree AV block, HR \\\u003C 60, or SBP \\\u003C100 mmHg) + 2 cycles of intermittent balloon inflation",[9],[25],{"name":26,"affiliation":27,"role":28},"Ahmad Samir","Aswan Heart Centre","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","1002647275","0020","ahmad.samir@kasralainy.edu.eg",{"type":28,"investigatorFullName":26,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"MD",[38],{"name":27,"class":6},"100469495","upfront-premedication-for-reduction-of-microvascular-obstruction-and-no-reflow-in-treating-st-segment-elevation-myocardial-infarction-100469495",false,"NCT05393557","Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction","UPFRONT-STEMI","Inclusion Criteria:\n\n* STEMI patients with time from symptom onset of \\\u003C 24 hours duration.\n* Large thrombus burden confirmed after initial wiring.\n* Radial vascular access.\n\nExclusion Criteria:\n\n* STEMI patients receiving successful fibrinolytic therapy.\n* TIMI flow ≥ 1 or TIMI thrombus grade ≤ 3 at initial wiring.\n* Refusal to participate int the study, or unable to be consented (unconscious or comatose patients).\n* Femoral access.\n* Previous infarction in the same territory.\n* Patients receiving PTCA only for acute reperfusion and planned for CABG.\n* Patients with known intolerance or contraindications for CMR, such as claustrophobic or those with mechanical heart valve prothesis, or implantable non-conditional heart rhythm devices.","ALL","18 Years","80 Years",{"count":50,"type":51},626,"ESTIMATED","INTERVENTIONAL",[54],"NA","Angiographic no-reflow during primary PCI procedures occurs at relatively high rate (25%) and is associated with worsening of long term morbidity and mortality. The exact mechanism of no-reflow is not fully understood, yet it is believed to be multifactorial including microvascular plugging with activated platelets and thrombotic debris in addition to the microvascular dysfunction from the ischaemia-reperfusion injury.\n\nDespite a theoretical advantage of glycoprotein IIb\u002FIIIa inhibitors (GPi) (like; Tirofiban) to suppress the intense platelets' activation\u002Freaction; their use did not lead to a significant net benefit, because it was opposed by increased risk of bleeding.\n\nHowever, the bleeding that plagued GPi use was predominantly related to vascular access in the era femoral approach was the default. Moreover, there are some recent data suggesting that small intracoronary bolus of GPi was non-inferior to intravenous bolus-infusion dose with less bleeding events.\n\nThis study plans to assess upfront premedication with small doses of GPi + Nitroglycerin ± Verapamil, with staged restoration of flow (repeated balloon inflation) to reduce angiographic no-reflow and CMR assessed microvascular occlusion (MVO).",[57,58,59],"STEMI","Large Thrombus Burden","No-Reflow Phenomenon",[61,57,62,63,64],"No reflow","Glycoprotein inhibitor","repeated intermittent balloon inflation","reperfusion injury","NOT_YET_RECRUITING","2023-08-30",{"date":68,"type":69},"2023-08-31","ACTUAL",{"date":71,"type":51},"2024-01-01",{"date":73,"type":51},"2026-11-30",{"name":5,"class":6}]