Aortic and Vascular Graft Infection Study: A Look at Causes and Outcomes
Official title: Clinical Characteristics, Treatment Strategies, and Prognostic Factors of Infectious Arterial Diseases: A Single-Center, Real-World, Ambispective Observational Cohort Study
Run by Shanghai Zhongshan Hospital · NCT07847346 · Data updated 2026-11-12
This study follows adults with suspected or confirmed infections of the aorta or vascular grafts to see what causes the infections and how they respond to treatment using blood tests, tissue samples, and imaging.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | November 1, 2036 |
| Study ends | November 1, 2041 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07847346 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with suspected or confirmed vascular infection involving the native arterial wall, graft, or endograft, evaluated at Zhongshan Hospital.
✕Probably not a fit
Patients without infectious involvement of the arterial wall or graft, or those with insufficient data for adjudication, may not benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The CAIGIS Cohort is an ambispective observational study at Zhongshan Hospital, Fudan University, building a comprehensive platform with clinical data, biospecimens, microbiology, imaging, and outcomes for vascular infections. It aims to test blood-based pathogen detection and other diagnostics against traditional tissue and operative samples, while tracking treatment decisions and patient outcomes over time. The study also investigates biomarkers and imaging data to understand disease activity and recurrence. It plans to support nested studies in diagnostics, prognosis, microbiology, and translational research. Data and samples will be collected from patients with suspected or confirmed infectious conditions of the arterial wall, grafts, or fistulas to facilitate longitudinal analyses.
Why it matters
Potential benefit: If successful, the study could improve diagnostic accuracy and speed for vascular infections and inform better treatment strategies.
How similar studies have gone: Prior research suggests that multi-modal diagnostics and molecular approaches can improve pathogen detection in vascular infections, but this cohort is one of the more comprehensive ambispective platforms.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged 18 years or older. 2. 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. 3. Patients evaluated or treated at Zhongshan Hospital, Fudan University, with sufficient clinical information to allow diagnostic adjudication and outcome assessment. 4. For the prospective cohort, willingness to participate and provide informed consent when required. 5. For the retrospective cohort, availability of relevant clinical records meeting the requirements approved by the institutional ethics committee. Exclusion Criteria: 1. Isolated superficial surgical-site infection without evidence of involvement of the arterial wall, vascular graft, or endograft. 2. Insufficient clinical data to permit diagnostic adjudication or longitudinal outcome assessment. 3. Refusal to participate in the prospective component when informed consent is required.
Where it's running
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Zhongshan Hospital, Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Qing Miao, MD, PhD
- Email: miao.qing@zs-hospital.sh.cn
- Phone: +8613917763967
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.