Clinical Characteristics, Treatment Strategies, and Prognostic Factors of Infectious Arterial Diseases: A Single-Center, Real-World, Ambispective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy
研究概览
简要总结
Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CnZS-VI 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.
The 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.
Another major focus is the role of molecular imaging, particularly 18F-FDG PET/CT, 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.
The 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.
By integrating longitudinal clinical data, microbiological results, molecular diagnostics, PET/CT 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.
详细描述
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.
The CnZS-VI 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.
Etiological 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.
The 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.
A further research focus is the role of 18F-FDG PET/CT and other imaging modalities in both diagnosis and longitudinal monitoring. The diagnostic performance and incremental value of PET/CT, particularly in patients with inconclusive conventional imaging, will be evaluated. Where serial PET/CT 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older.
- •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.
- •Patients evaluated or treated at Zhongshan Hospital, Fudan University, with sufficient clinical information to allow diagnostic adjudication and outcome assessment.
- •For the prospective cohort, willingness to participate and provide informed consent when required.
- •For the retrospective cohort, availability of relevant clinical records meeting the requirements approved by the institutional ethics committee.
排除标准
- •Isolated superficial surgical-site infection without evidence of involvement of the arterial wall, vascular graft, or endograft.
- •Insufficient clinical data to permit diagnostic adjudication or longitudinal outcome assessment.
- •Refusal to participate in the prospective component when informed consent is required.
研究组 & 干预措施
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.
结局指标
主要结局
Sustained Cure Rate One Year After Discontinuation of Antimicrobial Therapy
时间窗: 1 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.
Five-Year All-Cause Mortality
时间窗: 5 years after the index diagnosis
Proportion of participants who die from any cause within 5 years after the index diagnosis of vascular infection.
次要结局
- Proportion of Patients Requiring Lifelong Suppressive Antimicrobial Therapy(Up to 2 years after diagnosis)
- Five-Year Infection-Related Mortality(Up to 5 years after the index diagnosis)
研究者
Qing Miao
Associate Chief Physician
Shanghai Zhongshan Hospital
