[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353726":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":35,"locations":47,"responsibleParty":137,"collaborators":24,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":141,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":24,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":24,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Ottawa Heart Institute Research Corporation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemiarch repair","ACTIVE_COMPARATOR","Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.",[13],"Procedure: Hemiarch repair",{"label":15,"type":10,"description":16,"interventionNames":17},"Extended arch repair","Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.",[18],"Procedure: Extended arch repair",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.",[15],[29,32],{"name":30,"affiliation":5,"role":31},"Munir Boodhwani, MD","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Jehangir Appoo, MD","University of Calgary",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Khatira Mehdiyeva","CONTACT","613-696-7000","18328","kmehdiyeva@ottawaheart.ca",{"name":43,"role":38,"phone":44,"phoneExt":45,"email":46},"Alice Black","403-389-8958","613-696-7230","AlBlack@ottawaheart.ca",[48,70,89,114],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A5A5","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-81.23304,42.98339,{"lat":60,"lon":59},[63,68],{"name":64,"role":38,"phone":65,"phoneExt":66,"email":67},"Stephen Mardell","5196858500","34070","Stephen.Mardell@lhsc.on.ca",{"name":69,"role":31,"phone":24,"phoneExt":24,"email":24},"Michael Chu, MD",{"facility":71,"status":50,"city":72,"state":52,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University Health Network","Toronto","M5G 2C4",{"type":57,"coordinates":75},[76,77],-79.39864,43.70643,{"lat":77,"lon":76},[80,84,86],{"name":81,"role":38,"phone":82,"phoneExt":24,"email":83},"Waleed Alnimr","416 340 4800","Waleed.AlNimr@uhn.ca",{"name":85,"role":31,"phone":24,"phoneExt":24,"email":24},"Maral Ouzounian, MD",{"name":87,"role":88,"phone":24,"phoneExt":24,"email":24},"Jennifer Chung, MD","SUB_INVESTIGATOR",{"facility":90,"status":50,"city":91,"state":92,"zip":93,"country":54,"countryCode":55,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Montreal Heart Institute","Montreal","Quebec","H1T 1C8",{"type":57,"coordinates":95},[96,97],-73.58781,45.50884,{"lat":97,"lon":96},[100,105,108,110,112],{"name":101,"role":38,"phone":102,"phoneExt":103,"email":104},"Asma Hamlili","514-376-3330","3725","asma.hamlili@icm-mhi.org",{"name":106,"role":38,"phone":102,"phoneExt":103,"email":107},"Alexandre Bergeron","alexandre.bergeron.icm@icm-mhi.org",{"name":109,"role":31,"phone":24,"phoneExt":24,"email":24},"Philippe Demers, MD",{"name":111,"role":88,"phone":24,"phoneExt":24,"email":24},"Marina Ibrahim, MD",{"name":113,"role":88,"phone":24,"phoneExt":24,"email":24},"Raymond Cartier, MD",{"facility":115,"status":50,"city":116,"state":92,"zip":117,"country":54,"countryCode":55,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Institut Universitaire De Cardiologie Et De Pneumologie de Québec","Québec","G1V 4G5",{"type":57,"coordinates":119},[120,121],-71.21454,46.81228,{"lat":121,"lon":120},[124,129,131,133,135],{"name":125,"role":38,"phone":126,"phoneExt":127,"email":128},"Annie Bergeron","418-656-8711","2768","annie.bergeron@criucpq.ulaval.ca",{"name":130,"role":31,"phone":24,"phoneExt":24,"email":24},"François Dagenais, MD",{"name":132,"role":88,"phone":24,"phoneExt":24,"email":24},"Eric Dumont, MD",{"name":134,"role":88,"phone":24,"phoneExt":24,"email":24},"Charles Laurin, MD",{"name":136,"role":88,"phone":24,"phoneExt":24,"email":24},"Jean Porterie, MD",{"type":138,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100353726","hemiarch-vs-extended-arch-in-type-1-aortic-dissection-100353726",false,"NCT03885635","Hemiarch vs Extended Arch in Type 1 Aortic Dissection","Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)","HEADSTART","Inclusion Criteria\n\n1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection\n2. Age \\>18 years and \\\u003C70 years\n3. Operating surgeon believes that both surgeries could be safe and effective\n\nExclusion Criteria\n\n1. Hemodynamic instability\u002Fshock defined as systolic BP \\\u003C 90 mm Hg\n2. Previous cardiac surgery with sternotomy or thoracic endograft placement\n3. Aortic arch diameter \\> 6cm in which a concomitant arch replacement is judged necessary\n4. Procedures deemed to be \"salvage operations\" where the patient is unlikely to survive hospital discharge.\n5. GCS \\\u003C 8 for more than 6 hours\n6. History of cirrhosis.\n7. History of chronic renal failure (baseline eGFR \\\u003C 50)\n8. Metastatic malignancy\n9. Pregnancy","ALL","18 Years","70 Years",{"count":151,"type":152},50,"ESTIMATED","INTERVENTIONAL",[155],"NA","HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.",[158],"Aortic Dissection","2025-09-17",{"date":161,"type":162},"2025-09-22","ACTUAL",{"date":164,"type":162},"2024-07-30",{"date":166,"type":152},"2027-03-31",{"name":5,"class":6},4]