[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658140":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":35,"overallOfficials":35,"centralContacts":44,"locations":53,"responsibleParty":70,"collaborators":35,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":35,"enrollmentInfo":85,"targetDuration":35,"studyType":88,"phases":35,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":56,"whyStopped":35,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy","Proportion of participants who remain alive and free from persistent or recurrent vascular infection for 1 year after discontinuation of antimicrobial therapy, without reinitiation of antimicrobial treatment for the index vascular infection or unplanned infection-related surgical or endovascular intervention.","1 year after discontinuation of antimicrobial therapy",{"measure":14,"description":15,"timeFrame":16},"Five-Year All-Cause Mortality","Proportion of participants who die from any cause within 5 years after the index diagnosis of vascular infection.","5 years after the index diagnosis",[18,22],{"measure":19,"description":20,"timeFrame":21},"Proportion of Patients Requiring Lifelong Suppressive Antimicrobial Therapy","Proportion of participants requiring indefinite or lifelong suppressive antimicrobial therapy because complete eradication of vascular infection is not considered achievable. The proportion will be assessed separately among patients managed conservatively and those undergoing surgical or endovascular treatment.","Up to 2 years after diagnosis",{"measure":23,"description":24,"timeFrame":25},"Five-Year Infection-Related Mortality","Percentage of participants who die from causes directly or indirectly attributable to the index vascular infection within 5 years after the index diagnosis. Infection-related death will be determined by multidisciplinary clinical adjudication based on the clinical course, microbiological findings, imaging, operative findings, and documented cause of death.","Up to 5 years after the index diagnosis",[27,31],{"measure":28,"description":29,"timeFrame":30},"Incremental Diagnostic Yield of Individual Diagnostic Technologies","Proportion of participants in whom an additional etiological diagnosis is established by a specific diagnostic modality beyond conventional microbiological evaluation. Incremental diagnostic yield will be assessed separately for blood-based molecular diagnostics, including liquid biopsy approaches, serological testing, molecular testing of local or operative specimens, and other advanced diagnostic methods where available.","Within 90 days after the index diagnosis",{"measure":32,"description":32,"timeFrame":33},"Rate of Diagnostic Test-Related Changes in Clinical Management","From enrollment to 90 days after the index diagnosis",{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":36,"timePerspective":37,"maskingInfo":35},null,"COHORT","PROSPECTIVE","Vascular infections encompass a heterogeneous group of severe infectious diseases involving the arterial wall, vascular grafts, or endografts, including infectious aortitis, infected arterial aneurysms, vascular graft and endograft infections, and fistula-associated vascular infections. These conditions are associated with substantial morbidity and mortality and remain challenging with respect to etiological diagnosis, assessment of disease activity, therapeutic decision-making, and prediction of recurrence and long-term outcomes.\n\nThe CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University. The study is designed as a longitudinal clinical research platform integrating standardized clinical data, microbiological investigations, molecular diagnostics, imaging, treatment information, outcome assessment, and longitudinal biospecimen collection. Patients with suspected or confirmed vascular infections will be included and followed longitudinally. In addition to characterization of the overall disease spectrum, the cohort will serve as a platform for multiple nested diagnostic, prognostic, microbiological, imaging, and translational studies.\n\nEtiological diagnosis and evaluation of diagnostic technologies constitute a major focus of the cohort. Conventional microbiological methods, including blood culture, operative specimen culture, histopathology, and pathogen-specific serological testing, will be evaluated together with emerging molecular diagnostic technologies. Particular attention will be given to blood-based pathogen detection as a form of liquid biopsy, including metagenomic and targeted sequencing approaches where available. Diagnostic yield, incremental diagnostic value, time to etiological diagnosis, concordance between blood and local-site specimens, and the clinical impact of different diagnostic strategies will be investigated. Operative tissue and prosthetic material, when available, will provide an important reference for evaluating blood-based diagnostic approaches.\n\nThe cohort will also investigate dynamic biomarkers for disease activity and prognosis. Serial blood samples obtained during diagnosis, treatment, and follow-up may be used to characterize changes in pathogen-derived signals and host-response biomarkers. Their associations with microbiological clearance, treatment response, persistent infection, recurrence, reoperation, and mortality will be explored. The long-term objective is to develop integrated diagnostic and prognostic models combining clinical, microbiological, molecular, imaging, and host-response information.\n\nA further research focus is the role of 18F-FDG PET\u002FCT and other imaging modalities in both diagnosis and longitudinal monitoring. The diagnostic performance and incremental value of PET\u002FCT, particularly in patients with inconclusive conventional imaging, will be evaluated. Where serial PET\u002FCT examinations are clinically available, changes in metabolic activity and imaging patterns will be studied in relation to treatment response, residual infection, recurrence, and prognosis. Quantitative and semi-quantitative imaging parameters may be integrated with microbiological and biomarker data to investigate whether multimodal assessment can improve disease classification and therapeutic monitoring.\n\nFistula-associated vascular infection, particularly vascular-enteric fistula-associated infection, represents another key area of investigation. These patients often demonstrate complex polymicrobial patterns and may undergo substantial changes in microbial composition during antimicrobial treatment, surgery, and postoperative recovery. Serial blood, operative tissue, fistula-adjacent specimens, and other clinically obtained samples may therefore be used to characterize the longitudinal dynamics of microbial communities, distinguish vascular pathogens from enteric-source organisms, and explore the relationship between microbial composition, fistula status, treatment strategy, and clinical outcome.\n\nThe cohort will also support pathogen-specific translational studies. For Candida species, research will focus on distinguishing colonization or contamination from clinically significant invasive vascular infection and identifying microbiological, imaging, host, and clinical features associated with invasive disease and adverse outcomes. For mycobacterial vascular infections, including infections caused by Mycobacterium tuberculosis and nontuberculous mycobacteria, studies will investigate clinical characteristics, diagnostic features, microbial determinants, host susceptibility, and potential mechanisms underlying vascular tropism and persistent infection.\n\nIn patients undergoing surgery, infected vascular tissues and prosthetic materials may additionally be used to investigate in situ pathogen-host interactions. These studies may examine the spatial distribution of pathogens within infected tissue, local inflammatory and immune responses, tissue injury, and the relationship between microbial localization and pathological phenotype. Depending on specimen availability and individual nested study protocols, approaches may include microbiological, histopathological, molecular, genomic, transcriptomic, and spatial analyses.\n\nThrough the integration of clinical phenotyping, longitudinal biospecimen collection, pathogen-oriented diagnostics, liquid biopsy, molecular imaging, prognostic biomarkers, and translational investigation, the CAIGIS Cohort aims to establish a comprehensive research infrastructure for vascular infections. The overarching goal is to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and mechanistic understanding of these complex infections.","The study population consists of consecutive adult patients evaluated or treated at Zhongshan Hospital, Fudan University, for suspected or confirmed vascular infections involving the native arterial wall, vascular grafts, or endografts. The cohort includes infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. The ambispective design includes retrospectively identified patients with adequate clinical records and prospectively enrolled patients undergoing longitudinal follow-up. Clinical, microbiological, imaging, treatment, and outcome data will be collected, and biospecimens will be retained when available. Final diagnostic classification will be determined by multidisciplinary adjudication integrating clinical presentation, microbiological and molecular findings, imaging, pathology, operative findings, and longitudinal clinical course.",[41],{"label":42,"type":35,"description":43,"interventionNames":35},"Patients With Vascular Infections","Patients with suspected or confirmed vascular infections, including infectious aortitis, infected arterial aneurysms, vascular graft or endograft infections, and fistula-associated vascular infections. Clinical, microbiological, molecular diagnostic, imaging, treatment, outcome, and biospecimen data will be collected longitudinally to support diagnostic, prognostic, and translational studies.",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":35,"email":49},"Qing Miao, MD, PhD","CONTACT","+8613917763967","miao.qing@zs-hospital.sh.cn",{"name":51,"role":47,"phone":35,"phoneExt":35,"email":52},"Jianing Yue, MD, PhD","yuejianing@gmail.com",[54],{"facility":55,"status":56,"city":57,"state":35,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","200032","China","CN",{"type":62,"coordinates":63},"Point",[64,65],121.45806,31.22222,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":48,"phoneExt":35,"email":49},"QING MIAO, MD,PHD",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Qing Miao","Associate Chief Physician","100658140","aortic-infection-and-graft-infection-an-ambispective-cohort-study-in-china-100658140",false,"NCT07847346","China Aortic Infection and Graft Infection Study: An Ambispective Cohort","Clinical Characteristics, Treatment Strategies, and Prognostic Factors of Infectious Arterial Diseases: A Single-Center, Real-World, Ambispective Observational Cohort Study","CAIGIS","Inclusion Criteria:\n\n1. Adults aged 18 years or older.\n2. Patients with suspected or confirmed vascular infection involving the native arterial wall, vascular graft, or endograft, including but not limited to infectious aortitis, infected arterial aneurysm, vascular graft or endograft infection, and fistula-associated vascular infection.\n3. Patients evaluated or treated at Zhongshan Hospital, Fudan University, with sufficient clinical information to allow diagnostic adjudication and outcome assessment.\n4. For the prospective cohort, willingness to participate and provide informed consent when required.\n5. For the retrospective cohort, availability of relevant clinical records meeting the requirements approved by the institutional ethics committee.\n\nExclusion Criteria:\n\n1. Isolated superficial surgical-site infection without evidence of involvement of the arterial wall, vascular graft, or endograft.\n2. Insufficient clinical data to permit diagnostic adjudication or longitudinal outcome assessment.\n3. Refusal to participate in the prospective component when informed consent is required.",true,"ALL","18 Years",{"count":86,"type":87},2000,"ESTIMATED","OBSERVATIONAL","Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University, to create an integrated clinical research platform and biobank for patients with suspected or confirmed vascular infections.\n\nThe primary research focus is the diagnosis and characterization of causative pathogens. Conventional microbiological methods and emerging molecular diagnostic technologies will be systematically evaluated, with particular emphasis on blood-based pathogen detection as a form of liquid biopsy and its diagnostic value compared with local tissue or operative specimens. Serial blood samples and tissue specimens, when available, will also be used to investigate biomarkers associated with treatment response and clinical outcomes.\n\nAnother major focus is the role of molecular imaging, particularly 18F-FDG PET\u002FCT, in the diagnosis and longitudinal assessment of vascular infections. The study will evaluate its diagnostic performance, its added value in patients with inconclusive conventional imaging, and the potential significance of changes in metabolic activity during follow-up for assessing treatment response, residual infection, recurrence, and prognosis.\n\nThe cohort will further support nested translational studies addressing specific pathogen- and disease-related questions. These include longitudinal characterization of microbial communities in patients with vascular-enteric fistulas; evaluation of the clinical significance and invasive potential of Candida species; investigation of the clinical and biological characteristics of mycobacterial vascular infections; and exploration of pathogen-host interactions within infected vascular tissues.\n\nBy integrating longitudinal clinical data, microbiological results, molecular diagnostics, PET\u002FCT findings, treatment information, outcomes, and biospecimens, the cohort aims to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and understanding of the pathogenesis of vascular infections.",[91,92,93],"Vascular Graft Infection","Infectious Aortitis","Aortoenteric Fistula",[95,96,97,98,99,100,101,102,103],"Vascular graft and endograft infection","Infectious aneurysm","Aortoenteric fistula","Metagenomic next-generation sequencing","Liquid biopsy","18F-FDG PET\u002FCT","Mycobacterium","Pathogen-host interaction","Microbiome","2026-09-29",{"date":106,"type":107},"2026-10-02","ACTUAL",{"date":109,"type":87},"2026-11-01",{"date":111,"type":87},"2041-11-01",{"name":5,"class":6},1]