[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362371":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":52,"locations":62,"responsibleParty":350,"collaborators":31,"id":352,"slug":353,"hasResults":354,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":354,"sex":360,"minAge":361,"maxAge":31,"enrollmentInfo":362,"targetDuration":31,"studyType":365,"phases":366,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":84,"whyStopped":31,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":391},{"fullName":5,"class":6},"University of Sydney","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tenecteplase (1\u002F3 systemic weight based dose)","EXPERIMENTAL","Tenecteplase will be reconstituted in 20mL sterile water for injection at 1\u002F3 of the weight based dose, and administered by intracoronary infusion over 3 minutes.",[13],"Drug: Tenecteplase (1\u002F3 systemic weight based dose)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sterile Water for injection (WFI)","PLACEBO_COMPARATOR","Water for injection will be prepared to 20mL over an equivalent time period to the reconstitution time of the experimental arm, in order to maintain the blind, and administered by intracoronary infusion over 3 minutes.",[19],"Other: Sterile water for injection (WFI)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","50mg reconstituted to 20mL for intracoronary infusion at 1\u002F3 weight based dose.",[9],[26],"TNKase",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Sterile water for injection (WFI)","Placebo comparative arm.",[15],null,[33,37,40,43,46,49],{"name":34,"affiliation":35,"role":36},"Martin Ng, MBBS (Hons)","Royal Prince Alfred Hospital, Sydney, Australia","STUDY_CHAIR",{"name":38,"affiliation":39,"role":36},"Andy Yong, MBBS","Concord Repatriation General Hospital",{"name":41,"affiliation":42,"role":36},"Anthony Keech, MBBS","National Health and Medical Research Council, Australia",{"name":44,"affiliation":45,"role":36},"William Fearon, MD","Stanford University",{"name":47,"affiliation":48,"role":36},"Jamie Layland, MBBS","Peninsula Health",{"name":50,"affiliation":51,"role":36},"Harvey White, FRCS","Green Lane Cardiovascular Service",[53,57],{"name":34,"role":54,"phone":55,"phoneExt":31,"email":56},"CONTACT","+614 3407 8507","martin.ng@sydney.edu.au",{"name":58,"role":54,"phone":59,"phoneExt":60,"email":61},"Rebecca Mister","+612 9562 5000","5342","RESTORE-MI.Study@sydney.edu.au",[63,82,94,106,118,132,146,160,170,185,198,211,223,230,243,257,271,286,300,314,326,338],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Bankstown-Lidcombe Hospital","NOT_YET_RECRUITING","Bankstown","New South Wales","2200","Australia","AU",{"type":72,"coordinates":73},"Point",[74,75],151.03333,-33.91667,{"lat":75,"lon":74},[78],{"name":79,"role":54,"phone":80,"phoneExt":31,"email":81},"Kaleab Asrress","+612 9722 8486","kaleab.asrress@sydney.edu.au",{"facility":83,"status":84,"city":85,"state":67,"zip":86,"country":69,"countryCode":70,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Royal Prince Alfred Hospital","RECRUITING","Camperdown","2050",{"type":72,"coordinates":88},[89,90],151.17642,-33.88965,{"lat":90,"lon":89},[93],{"name":34,"role":54,"phone":55,"phoneExt":31,"email":56},{"facility":39,"status":84,"city":95,"state":67,"zip":96,"country":69,"countryCode":70,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Concord","2139",{"type":72,"coordinates":98},[99,100],151.10381,-33.84722,{"lat":100,"lon":99},[103],{"name":38,"role":54,"phone":104,"phoneExt":31,"email":105},"+614 0130 1790","sze.yong@sydney.edu.au",{"facility":107,"status":65,"city":108,"state":67,"zip":109,"country":69,"countryCode":70,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Northern Beaches Hospital","Frenchs Forest","2086",{"type":72,"coordinates":111},[112,113],151.22322,-33.74821,{"lat":113,"lon":112},[116],{"name":117,"role":54,"phone":31,"phoneExt":31,"email":31},"Antony Lau",{"facility":119,"status":84,"city":120,"state":67,"zip":121,"country":69,"countryCode":70,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Liverpool Hospital","Liverpool","2170",{"type":72,"coordinates":123},[124,125],150.92588,-33.91938,{"lat":125,"lon":124},[128],{"name":129,"role":54,"phone":130,"phoneExt":31,"email":131},"Sidney Lo","(02) 8738 3051","sidney.lo@health.nsw.gov.au",{"facility":133,"status":84,"city":134,"state":67,"zip":135,"country":69,"countryCode":70,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"John Hunter Hospital","New Lambton Heights","2305",{"type":72,"coordinates":137},[138,139],151.69364,-32.92466,{"lat":139,"lon":138},[142],{"name":143,"role":54,"phone":144,"phoneExt":31,"email":145},"Andrew Boyle","(02) 4921 4720","Andrew.Boyle@health.nsw.gov.au",{"facility":147,"status":65,"city":148,"state":67,"zip":149,"country":69,"countryCode":70,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Prince of Wales Hospital","Randwick","2031",{"type":72,"coordinates":151},[152,153],151.24895,-33.91439,{"lat":153,"lon":152},[156],{"name":157,"role":54,"phone":158,"phoneExt":31,"email":159},"Sze-Yuan Ooi","(02) 9382 0770","szeyuan.ooi@ehc.com.au",{"facility":161,"status":162,"city":163,"state":67,"zip":164,"country":69,"countryCode":70,"cosmosGeoPoint":165,"geoPoint":169,"contacts":31},"Wollongong Hospital","WITHDRAWN","Wollongong","2500",{"type":72,"coordinates":166},[167,168],150.89345,-34.424,{"lat":168,"lon":167},{"facility":171,"status":84,"city":172,"state":173,"zip":174,"country":69,"countryCode":70,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":72,"coordinates":176},[177,178],138.59863,-34.92866,{"lat":178,"lon":177},[181],{"name":182,"role":54,"phone":183,"phoneExt":31,"email":184},"Jerrett Lau","(08) 7074 1796","jerrett.lau@sa.gov.au",{"facility":186,"status":84,"city":187,"state":173,"zip":188,"country":69,"countryCode":70,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Lyell McEwin Hospital","Elizabeth Vale","5112",{"type":72,"coordinates":190},[191,192],138.66819,-34.74857,{"lat":192,"lon":191},[195],{"name":196,"role":54,"phone":31,"phoneExt":31,"email":197},"Purendra Pati","Purendra.Pati@sa.gov.au",{"facility":199,"status":84,"city":200,"state":201,"zip":202,"country":69,"countryCode":70,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Box Hill Hospital","Box Hill","Victoria","3128",{"type":72,"coordinates":204},[205,206],145.12545,-37.81887,{"lat":206,"lon":205},[209],{"name":210,"role":54,"phone":31,"phoneExt":31,"email":31},"Jaya Chandrasekhar",{"facility":212,"status":84,"city":213,"state":201,"zip":214,"country":69,"countryCode":70,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Jessie McPherson Private Hospital","Clayton","3168",{"type":72,"coordinates":216},[217,218],145.11667,-37.91667,{"lat":218,"lon":217},[221],{"name":222,"role":54,"phone":31,"phoneExt":31,"email":31},"Robert Gooley",{"facility":224,"status":84,"city":213,"state":201,"zip":214,"country":69,"countryCode":70,"cosmosGeoPoint":225,"geoPoint":227,"contacts":228},"Victorian Heart Hospital",{"type":72,"coordinates":226},[217,218],{"lat":218,"lon":217},[229],{"name":222,"role":54,"phone":31,"phoneExt":31,"email":31},{"facility":231,"status":84,"city":232,"state":201,"zip":233,"country":69,"countryCode":70,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"The Northern Hospital","Epping","3076",{"type":72,"coordinates":235},[236,237],145.03333,-37.65,{"lat":237,"lon":236},[240],{"name":241,"role":54,"phone":31,"phoneExt":31,"email":242},"William van Gaal","William.vangaal@nh.org.au",{"facility":244,"status":84,"city":245,"state":201,"zip":246,"country":69,"countryCode":70,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Frankston Hospital","Frankston","3199",{"type":72,"coordinates":248},[249,250],145.12291,-38.14458,{"lat":250,"lon":249},[253],{"name":254,"role":54,"phone":255,"phoneExt":31,"email":256},"Jamie Layland","(03) 9748 2687","jlayland@phcn.vic.gov.au",{"facility":258,"status":84,"city":259,"state":201,"zip":260,"country":69,"countryCode":70,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Sunshine Hospital","Saint Albans","3021",{"type":72,"coordinates":262},[263,264],144.8,-37.73333,{"lat":264,"lon":263},[267],{"name":268,"role":54,"phone":269,"phoneExt":31,"email":270},"William Chan","0435 612 868","william.chan@unimelb.edu.au",{"facility":272,"status":65,"city":273,"state":274,"zip":275,"country":69,"countryCode":70,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Fiona Stanley Hospital","Murdoch","Western Australia","6150",{"type":72,"coordinates":277},[278,279],115.83757,-32.06987,{"lat":279,"lon":278},[282],{"name":283,"role":54,"phone":284,"phoneExt":31,"email":285},"Matthew Erickson","08 6152 6604","matthew.erickson@health.wa.gov.au",{"facility":287,"status":84,"city":288,"state":274,"zip":289,"country":69,"countryCode":70,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Royal Perth Hospital","Perth","6000",{"type":72,"coordinates":291},[292,293],115.8614,-31.95224,{"lat":293,"lon":292},[296],{"name":297,"role":54,"phone":298,"phoneExt":31,"email":299},"Jonathan Spiro","(08) 9224 3290","Jonathan.Spiro@health.wa.gov.au",{"facility":301,"status":65,"city":302,"state":31,"zip":303,"country":304,"countryCode":305,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Auckland City Hospital","Auckland","1023","New Zealand","NZ",{"type":72,"coordinates":307},[308,309],174.76349,-36.84853,{"lat":309,"lon":308},[312],{"name":313,"role":54,"phone":31,"phoneExt":31,"email":31},"Jithendra Somaratne",{"facility":315,"status":65,"city":316,"state":31,"zip":317,"country":304,"countryCode":305,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Christchurch Hospital","Christchurch","4710",{"type":72,"coordinates":319},[320,321],172.63333,-43.53333,{"lat":321,"lon":320},[324],{"name":325,"role":54,"phone":31,"phoneExt":31,"email":31},"Aniket Puri",{"facility":327,"status":84,"city":328,"state":31,"zip":329,"country":304,"countryCode":305,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Waikato Hospital","Hamilton","3240",{"type":72,"coordinates":331},[332,333],175.28333,-37.78333,{"lat":333,"lon":332},[336],{"name":337,"role":54,"phone":31,"phoneExt":31,"email":31},"Sanjeevan Pasupati",{"facility":339,"status":65,"city":340,"state":31,"zip":341,"country":304,"countryCode":305,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Wellington Hospital","Wellington","2820",{"type":72,"coordinates":343},[344,345],174.77557,-41.28664,{"lat":345,"lon":344},[348],{"name":349,"role":54,"phone":31,"phoneExt":31,"email":31},"Scott Harding",{"type":351,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100362371","phase-3-a-study-of-low-dose-intracoronary-thrombolytic-therapy-in-stemi-heart-attack-patients-100362371",false,"NCT03998319","A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.","A Randomised Trial to Evaluate the Efficacy of Low-dose Intracoronary Tenecteplase in ST-Elevation Myocardial Infarction (STEMI) Patients With High Microvascular Resistance Post-percutaneous Coronary Intervention (PCI).","RESTORE-MI","Inclusion Criteria:\n\n1. Adult men and women aged over 18 who present with STEMI within 6 hours of symptom onset. Patients will be eligible if they have symptoms consistent with myocardial ischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definite ECGs indicating STEMI as defined by Australian National Heart Foundation (NHF) guidelines\n2. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances\n3. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study\n4. (At time of PCI) Patient has received metallic drug-eluting stent\n5. Participant consents to have a 3-7 day (discharge) and 6 month follow up cardiac MRI\n\nExclusion Criteria:\n\nAt the time of screening and\u002For prior to randomisation, no known;\n\n1. Previous coronary bypass grafting\n2. Other residual lesions with ≥50% diameter stenosis in the culprit vessel\n3. Prior myocardial infarction in the target territory\n4. Presence of contraindications to thrombolytic therapy (including history of stroke and recent brain surgery active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension)\n5. Presence of contraindications to adenosine infusion for IMR measurement including sinus node disease, moderate to severe bronchoconstrictive disease and second or third-degree atrioventricular (AV) block\n6. Diagnosis of metastatic disease\n7. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol\n9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.\n10. Participation in any investigational study in the previous 30 days\n\n    Other exclusion criteria:\n11. (Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRI including severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysm clips, defibrillators and estimated glomerular filtration rate of \\<30mL\u002Fmin.\n\n    (At time of PCI)\n12. Patients who received GpIIb\u002FIIIa treatment prior to IMR measurement\n13. Patients who do not undergo primary PCI due to lack of severity of culprit lesion or other reasons.","ALL","18 Years",{"count":363,"type":364},445,"ESTIMATED","INTERVENTIONAL",[367],"PHASE3","Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving can cause this clot to break up and get washed downstream, which can make the heart attack worse. The investigators can measure the amount of damage caused to the microcirculation by calculating the IMR (Index of Microcirculatory resistance).\n\nThis can be measured by a wire in the coronary artery with a pressure sensor at the tip. If the IMR is elevated, it is suggestive of extensive microcirculatory damage. A clot dissolving medicine can be administered in the artery to try and reduce the IMR which can reduce damage to the heart muscle and improve outcomes.\n\nImpaired microcirculatory perfusion in patients as a result of ST-elevation myocardial infarction (STEMI) is associated with poor clinical outcomes. This project seeks to identify patients with impaired microcirculatory perfusion after STEMI and to assess whether acute improvement in microcirculatory perfusion in these patients by the use of intracoronary thrombolytic therapy results in improved clinical outcomes.",[370,371],"STEMI","Elevated IMR (>32)",[370,373,374,375,376,377,378,379,380,381],"IMR","microcirculation","microvascular obstruction","myocardial infarction","physiology","angioplasty","PCI","thrombolysis treatment","thrombolysis","2024-09-25",{"date":384,"type":385},"2024-09-27","ACTUAL",{"date":387,"type":385},"2021-10-14",{"date":389,"type":364},"2026-12-31",{"name":5,"class":6},22]