[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617303":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":89,"collaborators":43,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":43,"enrollmentInfo":102,"targetDuration":43,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":120,"whyStopped":43,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","ACTIVE_COMPARATOR","Intervention group: normothermic cardiopulmonary bypass with nasopharyngeal temperature of 36.5 ± 0.2°C",[13],"Procedure: Normothermic cardiopulmonary bypass",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Control group: mild hypothermic cardiopulmonary bypass with nasopharyngeal temperature of 33 ± 0.2°C",[18],"Procedure: Hypothermic cardiopulmonary bypass",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Normothermic cardiopulmonary bypass","normothermic cardiopulmonary bypass with nasopharyngeal temperature of 36.5 ± 0.2°C",[9],[26],"36.5 ± 0.2°C",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Hypothermic cardiopulmonary bypass","mild hypothermic cardiopulmonary bypass with nasopharyngeal temperature of 33 ± 0.2°C",[15],[32],"33 ± 0.2°C",[34],{"name":35,"affiliation":36,"role":37},"Timo Laitio, MD, PhD","Turku University Hospital, Wellbeing Services County of Southwest Finland","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Timo Laitio, M.D., PhD","CONTACT","+358504731639",null,"timo.laitio@varha.fi",[46],{"facility":5,"status":43,"city":47,"state":43,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Turku","FIN-20521","Finland","FI",{"type":52,"coordinates":53},"Point",[54,55],22.26869,60.45148,{"lat":55,"lon":54},[58,59,60,63,65,67,69,71,73,75,77,79,81,83,85,87],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":35,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":61,"role":62,"phone":43,"phoneExt":43,"email":43},"Toni Hentula, Master of health care","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":43,"phoneExt":43,"email":43},"Juha Grönlund, MD, PhD",{"name":66,"role":62,"phone":43,"phoneExt":43,"email":43},"Jussi Hirvonen, MD, PhD",{"name":68,"role":62,"phone":43,"phoneExt":43,"email":43},"Ville-Veikko Hynninen, MD, PhD",{"name":70,"role":62,"phone":43,"phoneExt":43,"email":43},"Markus Malmberg, MD, PhD",{"name":72,"role":62,"phone":43,"phoneExt":43,"email":43},"Ville Peltonen, MD",{"name":74,"role":62,"phone":43,"phoneExt":43,"email":43},"Teija Sainio, PhD",{"name":76,"role":62,"phone":43,"phoneExt":43,"email":43},"Jenni Toivonen, MD, PhD",{"name":78,"role":62,"phone":43,"phoneExt":43,"email":43},"Jussi Posti, MD, PhD",{"name":80,"role":62,"phone":43,"phoneExt":43,"email":43},"Timo Roine, PhD, M.Sc.(Tech.)",{"name":82,"role":62,"phone":43,"phoneExt":43,"email":43},"Jani Saunavaara, PhD",{"name":84,"role":62,"phone":43,"phoneExt":43,"email":43},"Antti Saraste, MD, PhD",{"name":86,"role":62,"phone":43,"phoneExt":43,"email":43},"Kalle-Oskari Suvanto, M.Sc (Tech)",{"name":88,"role":62,"phone":43,"phoneExt":43,"email":43},"Tero Vahlberg, MSc",{"type":37,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Timo Laitio","Professor","100617303","neuroprotective-effect-of-mild-hypothermia-versus-normothermia-during-cardiopulmonary-bypass-of-coronary-artery-surgery-100617303",false,"NCT07316868","Neuroprotective Effect of Mild Hypothermia Versus Normothermia During Cardiopulmonary Bypass of Coronary Artery Surgery","Neuroprotective Effect of Mild Hypothermia as Compared With Normothermia During Cardiopulmonary Bypass of Coronary Artery Bypass Grafting - A Single-center Randomized Controlled Trial","HYPNOCABG","Inclusion Criteria:\n\n1. Informed consent obtained\n2. Age of \\>18 years\n3. Undergoing elective or subacute coronary artery bypass grafting\n\nExclusion Criteria:\n\n1. An emergency case\n2. A history of stroke\n3. A history of intracranial bleeding\n4. A history of transient ischemic attack (TIA)\n5. A history of neurodegenerative diseases such as Alzheimer's, multiple sclerosis\n6. The subject is known to have a clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the subject to participate in this clinical trial.\n7. Presence of implants or foreign bodies which are not known to be MRI safe","ALL","18 Years",{"count":103,"type":104},160,"ESTIMATED","INTERVENTIONAL",[107],"NA","In high-income countries, coronary artery bypass grafting (CABG) remains a common procedure, with approximately 36.7 operations per 100,000 inhabitants annually, corresponding to about 136,000 procedures in the European Union. This highlights the substantial healthcare burden and the need to optimize surgical outcomes. Cardiopulmonary bypass (CPB) is a fundamental component of cardiac surgery, ensuring extracorporeal perfusion of vital organs.\n\nHypothermic CPB has historically been widely used for organ protection due to its presumed neuroprotective mechanisms. However, evidence demonstrating its superiority over normothermic CPB remains inconclusive. In its 2024 guidelines, the European Association for Cardio-Thoracic Surgery recommends considering normothermia (≥35 °C) to reduce postoperative neurocognitive dysfunction (Class II, Level A). This recommendation is primarily based on two meta-analyses, but the underlying studies show methodological heterogeneity, outdated practices, and limited applicability to contemporary cardiac surgery. Importantly, the guidelines acknowledge the need for large randomized controlled trials to define optimal target temperature management (TTM) during CPB.\n\nPrevious diffusion-weighted MRI studies have demonstrated silent ischemic brain lesions in approximately 30% of CABG patients, with postoperative neurocognitive decline occurring in a similar proportion. However, no significant differences have been shown between normothermic and hypothermic CPB. Diffusion tensor imaging (DTI) extends conventional diffusion imaging by enabling detailed assessment of white matter microstructure and tractography. Fractional anisotropy (FA), a key DTI metric, has demonstrated prognostic value in various neurological conditions but has not yet been applied in CABG patients.\n\nBlood-based biomarkers, including glial fibrillary acidic protein, neurofilament light chain, neuron-specific enolase, and total tau, offer complementary insights into brain injury but have not been studied in combination with DTI in this population.\n\nThis study will compare mild hypothermic (33-34 °C) and normothermic (36.5 °C) CPB to evaluate their neuroprotective effects using advanced MRI techniques and blood-based biomarkers. The primary aim is to determine whether mild hypothermia provides superior neuroprotection following CABG. Secondary objectives include assessing white matter injury evolution, global ischemic burden, associations with biomarkers and neurocognitive decline, and developing integrated prognostic models to improve outcomes in CABG patients.",[110,111],"Coronary Artery Disease","Brain Injury",[113,114,115,116,117,118,119],"hypothermia","normothermia","cardiopulmonary bypass","coronary artery bypass grafting","diffusion tensor imaging","neuroprotection","biomarkers","NOT_YET_RECRUITING","2025-12-18",{"date":123,"type":124},"2026-01-05","ACTUAL",{"date":126,"type":104},"2026-01-01",{"date":128,"type":104},"2029-12-31",{"name":5,"class":6},1]