[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital District of Helsinki and Uusimaa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"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":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34],"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",[36,37,38,39,40,41,42,43,44,45,46],"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","RECRUITING","2024-04-18",{"date":50,"type":51},"2024-04-19","ACTUAL",{"date":53,"type":51},"2024-04-01",{"date":55,"type":22},"2026-12-31",{"name":57,"class":58},"Hospital District of Helsinki and Uusimaa","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":17,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":59},"100418138","weight-bearing-of-surgically-treated-acetabular-fractures-100418138","NCT04724811","Weight-bearing of Surgically Treated Acetabular Fractures.","Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial","Inclusion Criteria:\n\n* Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)\n* The osteosynthesis is performed during 21 days after initial trauma\n* The patient is willing to participate in the follow-up\n\nExclusion Criteria:\n\n* Unwillingness to participate in randomisation\n* Bilateral fracture\n* Letournel \\& Judet type Both column or Posterior column and wall fractures\n* Any other injury that prevents the patient from partial weight bearing\n* Open fracture of the acetabulum\n* Pathologic fracture (fragility fractures are not an exclusion criteria)\n* Prior functional disability in the pelvis or lower extremity\n* Non-Compliance due to dementia or other mental disability\n* Prior daily pain medication due to hip-pain\n* Unwillingness to accept one of the two mobilisation protocols\n* Prior hip replacement on injured side\n* BMI \\> 40",true,"60 Years",{"count":21,"type":22},[25],"The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.\n\nBoth study groups are stratified according to\n\n* Type of fracture (anterior approach vs anterior + additional posterior approach)\n* Dislocated dome vs non-dislocated\u002F non existing separate dome fragment\n\nPatients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.",[73],"Acetabular Fracture",[75,76,77],"Acetabulum","Periarticular fracture","Weight-bearing","NOT_YET_RECRUITING","2024-03-05",{"date":81,"type":51},"2024-03-06",{"date":83,"type":22},"2024-05",{"date":85,"type":22},"2027-12",{"name":57,"class":58},""]