China Aortic Infection and Graft Infection Study: An Ambispective Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Patients With Vascular Infections
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year after discontinuation of antimicrobial therapy2
Five-Year All-Cause Mortality
Proportion of participants who die from any cause within 5 years after the index diagnosis of vascular infection.
Time frame
5 years after the index diagnosisSecondary outcomes
1
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.
Time frame
Up to 2 years after diagnosis2
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.
Time frame
Up to 5 years after the index diagnosisOther outcomes
1
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.
Time frame
Within 90 days after the index diagnosis2
Rate of Diagnostic Test-Related Changes in Clinical Management
Rate of Diagnostic Test-Related Changes in Clinical Management
Time frame
From enrollment to 90 days after the index diagnosisSponsors and contacts
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Source ClinicalTrials.gov