[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487848":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":76,"centralContacts":80,"locations":90,"responsibleParty":107,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":34,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":141,"overallStatus":93,"whyStopped":34,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Hospital District of Helsinki and Uusimaa","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"CABG + collaged-based patch arm (control)","ACTIVE_COMPARATOR","In total, 25 patients are recruited to form the CABG group. During CABG, RAA tissue is removed as detailed for the AAMs-patch group. However, the tissue is collected as a cryostored sample for later analyses rather than processed to AAMs (Method 4). CABG is performed without epicardial transplantation of AAMs, yet the collagen-based patch material is transplanted onto the epicardium of the scarred myocardium according the same principles as in the AAMs-patch intervention arm.",[13,14,15,16,17,18,19,20,21],"Diagnostic Test: RNA-stabilized whole blood sampling","Diagnostic Test: Plasma sampling","Diagnostic Test: Transthoracic echocardiography","Diagnostic Test: Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)","Other: Symptom-scaling","Other: 6-minute walking test (6MWT)","Diagnostic Test: Blood sampling (NT-proBNP)","Diagnostic Test: Transesophageal echocardiography","Procedure: Epicardial collagen-based patch transplantation",{"label":23,"type":24,"description":25,"interventionNames":26},"CABG + collagen based patch + AAMs arm (intervention)","EXPERIMENTAL","In total, 25 patients are recruited to the AAMs-patch group. Here, the AAMs are prepared from the RAA tissue sample by mechanical processing in the operating room during the CABG surgery. The RAA tissue piece is removed during right atrial cannulation, a part of the routine setup of cardiopulmonary bypass and mechanically processed to AAMs, which is allowed to gel with fibrinogen and thrombin in cold, covered, and sterile metallic dish until the last stages of CABG surgery. After all the coronary anastomoses are done, to form an AAMs-patch, the AAMs in a fibrin matrix gel are placed onto a collagen based matrix sheet and then epicardially transplanted onto the scar border area identified by preoperative LGE-CMRI to have most suffered from ischemia.",[27,13,14,15,16,17,18,19,20],"Procedure: Epicardial AAMs-patch transplantation",[29,35,40,44,50,54,58,62,66,72],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Epicardial AAMs-patch transplantation","Perioperative assembly of an AAMs-patch with epicardial transplantation onto the epicardium of the scarred myocardium at the end of CABG surgery",[23],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"DIAGNOSTIC_TEST","RNA-stabilized whole blood sampling","Collection (preoperative and at 6-month-follow-up) of TEMPUS(TM) stabilizing whole blood for epitranscriptomics-oriented measurements",[9,23],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"Plasma sampling","Collection (preoperative and at 6-month follow-up) of blood-derived both RNA-stabilized and non-stabilized plasma aliquots for epitranscriptomic-oriented and other CVD biomarker oriented measurements, respectively",[9,23],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Transthoracic echocardiography","To assess cardiac structure and function both pre- and postoperatively (at both hospital discharge and 3-month follow-up)",[9,23],[49],"TTE",{"type":36,"name":51,"description":52,"armGroupLabels":53,"otherNames":34},"Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)","To assess detailed cardiac structure (i.e. interstitial fibrosis) and function both preoperatively and at 6-month follow-up postoperatively.",[9,23],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":34},"Symptom-scaling","Standardised evaluation of IHD and HF-related angina pectoris (CCS) and dyspnea (NYHA) and life quality (RAND36) pre- and postoperatively (at both 3- and 6-month follow-up).",[9,23],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":34},"6-minute walking test (6MWT)","Standardised assessment of physcial capacity pre- and postoperatively (at 6-month follow-up)",[9,23],{"type":36,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"Blood sampling (NT-proBNP)","Collection of a blood sample measurement of NT-proBNP by an accredited hospital laboratory pre- and postoperatively (at both 3- and 6-month follow-up).",[9,23],{"type":36,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Transesophageal echocardiography","Performed by the perfusion-anesthesiologist at the beginning of the CABG surgery to evaluate both LAA and RAA for blood flow velocities, anatomy, possible sludge and thrombus.",[9,23],[71],"TEE",{"type":30,"name":73,"description":74,"armGroupLabels":75,"otherNames":34},"Epicardial collagen-based patch transplantation","Epicardial transplantation of the collaged-based patch material without the AAMs onto the epicardium of the scarred myocardium at the end of CABG surgery.",[9],[77],{"name":78,"affiliation":5,"role":79},"Antti Nykänen, Docent","PRINCIPAL_INVESTIGATOR",[81,86],{"name":78,"role":82,"phone":83,"phoneExt":84,"email":85},"CONTACT","050 427 0625","+358","antti.nykanen@hus.fi",{"name":87,"role":82,"phone":88,"phoneExt":84,"email":89},"Antti E Vento, Professor","050 427 0629","antti.vento@hus.fi",[91],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit","RECRUITING","Helsinki","Uusimaa","00029","Finland","FI",{"type":100,"coordinates":101},"Point",[102,103],24.93545,60.16952,{"lat":103,"lon":102},[106],{"name":78,"role":82,"phone":83,"phoneExt":84,"email":85},{"type":79,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Antti Nykanen","Docent Antti Nykänen, MD PhD",[111,113],{"name":112,"class":6},"University of Helsinki",{"name":114,"class":6},"Oulu University Hospital","100487848","atrial-appendage-micrograft-transplants-to-assist-heart-repair-after-cardiac-surgery-100487848",false,"NCT05632432","Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery","Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial","AAMS2","Inclusion Criteria:\n\n* Informed consent obtained\n* Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography)\n* New York Heart Association (NYHA) Class II-IV heart failure symptoms\n\nExclusion Criteria:\n\n* Heart failure due to left ventricular outflow tract obstruction\n* Acute myocardial infarction (AMI) within last 30 days\n* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator\n* Stroke or other disabling condition within 3 months before screening\n* Severe valve disease or scheduled valve surgery\n* Renal dysfunction (GFR \\\u003C45 ml\u002Fmin\u002F1.73m2)\n* Other disease limiting life expectancy\n* Contraindications for coronary angiogram or LGE-CMRI\n* Participation in some other clinical trial\n\nScreening Failure:\n\n* After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI\n* Preoperative LGE-CMRI has not been performed prior scheduled CABG","ALL","18 Years","75 Years",{"count":127,"type":128},50,"ESTIMATED","INTERVENTIONAL",[131],"NA","Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF).\n\nThe atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing.\n\nIn this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy.\n\nIn our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit.\n\nBased on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery.\n\nThe trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.",[134,135,136,137,138,139,140],"Ischemic Heart Disease","Ischemic Cardiomyopathy","Heart Failure, Systolic","Heart Failure NYHA Class III","Heart Failure NYHA Class II","Heart Failure NYHA Class IV","Coronary Artery Disease",[142,143,144,145,146,147,148,149,150,151,152],"Ischemic heart failure","Ischemic heart disease","Coronary artery disease","Coronary artery bypass grafting","Atrial appendage micrografts","Tissue-engineering","Ischemic cardiomyopathy","Atrial appendage","Micrografts","Cell Therapy","Epitranscriptomics","2024-04-18",{"date":155,"type":156},"2024-04-19","ACTUAL",{"date":158,"type":156},"2024-04-01",{"date":160,"type":128},"2026-12-31",{"name":5,"class":6},1]