[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582206":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Hospital Israelita Albert Einstein","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Coronary Plaques from Explanted Heart",null,"The selected arteries will be dissected and microscopically evaluated, and the samples will be fixed in formalin, embedded in paraffin, and stained for histological analysis. The tissue will be enzymatically dissociated to obtain individual cells, which will then be filtered and assessed for cell viability. The cells will undergo single-cell RNA sequencing (scRNAseq) with the aim of analyzing around 5,000-10,000 cells per sample. The sample size will be 20-30 plaques, with the goal of capturing the main cellular populations and performing a robust analysis.",[13],"Diagnostic Test: Single Cell RNA Sequencing",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Single Cell RNA Sequencing","Reprocessing\n\nData normalization, dimensionality reduction, and clustering will be performed using the Seurat package (based on R).\n\nCell types will be identified based on canonical marker gene expression. Cell Subpopulation Identification\n\nClusters will be annotated based on signatures of known cell types (e.g., endothelial cells, smooth muscle cells, macrophages, etc.).\n\nDifferential gene expression analysis will be conducted to identify disease-associated genes.\n\nPathway and Function Enrichment\n\nGene Set Enrichment Analysis (GSEA) and pathway analyses (e.g., KEGG, Reactome) will be carried out to investigate the biological processes and pathways driving atherosclerosis.\n\nQuality Control\n\nSequencing reads will be assessed for quality using FASTQC, and low-quality reads will be filtered out.\n\nThe Cell Ranger software (10x Genomics) will be used to align reads to the human genome and quantify gene expression at the single-cell level.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Carlos Vicente Serrano, PhD","CONTACT","+55 (11) 2151-5408","carlos.sjunior@einstein.br",[27],{"facility":5,"status":10,"city":28,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"São Paulo","05652-900","Brazil","BR",{"type":33,"coordinates":34},"Point",[35,36],-46.63611,-23.5475,{"lat":36,"lon":35},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Carlos Vicente Serrano Junior","Principal Investigator","100582206","immunoregulation-in-atherosclerosis-a-single-cell-rna-sequencing-study-100582206",false,"NCT06860295","\"Immunoregulation in Atherosclerosis: A Single-Cell RNA Sequencing Study\"","The Architectural Immunoregulation in Atherosclerotic Disease: A Single-Cell RNA Sequencing and Spatial Biology Approach","Inclusion Criteria:\n\n* Patients diagnosed with ischemic cardiomyopathy due to advanced atherosclerosis, undergoing heart transplantation;\n* Patients with coronary artery disease submitted to coronary artery bypass graft surgery (CABG).\"\n* Aged between 40 and 75 years;\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Patients with systemic inflammatory or autoimmune diseases;\n* History of cancer within the last 5 years or active malignancy;\n* Recent use (within the last 6 months) of immunosuppressive therapy.","ALL","45 Years","75 Years",{"count":53,"type":54},30,"ESTIMATED","2 Years","OBSERVATIONAL","Atherosclerosis is the leading cause of acute cardiovascular events, such as myocardial infarction and stroke, and is a significant risk factor for cardiovascular mortality. The detailed understanding of the immune mechanisms and cellular transformations involved in the pathogenesis of atherosclerosis is still limited, and the use of single-cell RNA sequencing (scRNAseq) has revealed new cellular functions and subpopulations associated with disease progression. This study aims to identify cellular subpopulations, molecular pathways, and changes in gene expression related to the development of atherosclerosis in human coronary arteries. Using scRNAseq, the study seeks to characterize the transcriptomic landscape of cells present in atherosclerotic plaques and identify molecular signatures that reveal individual predispositions to specific phenotypes, such as disease susceptibility and response to therapies. The research will be conducted at the Albert Einstein Israeli Hospital in São Paulo and will involve samples from coronary arteries and atherosclerotic plaques of the explanted hearts of patients who have undergone heart transplants as well as from discarded material of coronary artery bypass graft surgery (CABG). With an estimated sample size of 20-30 plaques, the data obtained will allow for a detailed analysis of the molecular mechanisms involved in atherosclerosis, contributing to the development of specific therapeutic targets.",[59],"Atherosclerosis of Coronary Artery",[61,62,63],"Atherosclerosis","Single Cell RNA-sequencing","Immunology","NOT_YET_RECRUITING","2025-06-09",{"date":67,"type":68},"2025-06-10","ACTUAL",{"date":70,"type":54},"2025-06-25",{"date":72,"type":54},"2027-04-25",{"name":5,"class":6},1]