China Aortic Infection and Graft Infection Study: An Ambispective Cohort

NCT07847346 | Recruiting

• 1 other identifier: CAIGIS-202611
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Graft Infection; Infectious Aortitis; Aortoenteric Fistula

Keywords

Vascular graft and endograft infection; Infectious aneurysm; Aortoenteric fistula; Metagenomic next-generation sequencing; Liquid biopsy; 18F-FDG PET/CT; Mycobacterium; Pathogen-host interaction; Microbiome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Incremental Diagnostic Yield of Individual Diagnostic Technologies

  Within 90 days after the index diagnosis

• Rate of Diagnostic Test-Related Changes in Clinical Management

  From enrollment to 90 days after the index diagnosis

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (8)

• Linder KA, Miceli MH. Impact of Metagenomic Next-Generation Sequencing of Plasma Cell-free DNA Testing in the Management of Patients With Suspected Infectious Diseases. Open Forum Infect Dis. 2023 Jul 24;10(8):ofad385. doi: 10.1093/ofid/ofad385. eCollection 2023 Aug.

  PMID: 37601730 RESULT

• Lauri C, Signore A, Glaudemans AWJM, Treglia G, Gheysens O, Slart RHJA, Iezzi R, Prakken NHJ, Debus ES, Honig S, Lejay A, Chakfe N. Evidence-based guideline of the European Association of Nuclear Medicine (EANM) on imaging infection in vascular grafts. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3430-3451. doi: 10.1007/s00259-022-05769-x. Epub 2022 Apr 4.

  PMID: 35376992 RESULT

• Husmann L, Sah BR, Scherrer A, Burger IA, Stolzmann P, Weber R, Rancic Z, Mayer D, Hasse B; VASGRA Cohort. (1)(8)F-FDG PET/CT for Therapy Control in Vascular Graft Infections: A First Feasibility Study. J Nucl Med. 2015 Jul;56(7):1024-9. doi: 10.2967/jnumed.115.156265. Epub 2015 May 14.

  PMID: 25977463 RESULT

• Ajdler-Schaeffler E, Scherrer AU, Keller PM, Anagnostopoulos A, Hofmann M, Rancic Z, Zinkernagel AS, Bloemberg GV, Hasse BK; and the VASGRA Cohort. Increased Pathogen Identification in Vascular Graft Infections by the Combined Use of Tissue Cultures and 16S rRNA Gene Polymerase Chain Reaction. Front Med (Lausanne). 2018 Jun 4;5:169. doi: 10.3389/fmed.2018.00169. eCollection 2018.

  PMID: 29915786 RESULT

• Anagnostopoulos A, Mayer F, Ledergerber B, Bergada-Pijuan J, Husmann L, Mestres CA, Rancic Z, Hasse B; VASGRA Cohort Study. Editor's Choice - Validation of the Management of Aortic Graft Infection Collaboration (MAGIC) Criteria for the Diagnosis of Vascular Graft/Endograft Infection: Results from the Prospective Vascular Graft Cohort Study. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):251-257. doi: 10.1016/j.ejvs.2021.05.010. Epub 2021 Jun 14.

  PMID: 34140225 RESULT

• Lyons OT, Baguneid M, Barwick TD, Bell RE, Foster N, Homer-Vanniasinkam S, Hopkins S, Hussain A, Katsanos K, Modarai B, Sandoe JA, Thomas S, Price NM. Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC). Eur J Vasc Endovasc Surg. 2016 Dec;52(6):758-763. doi: 10.1016/j.ejvs.2016.09.007. Epub 2016 Oct 19.

  PMID: 27771318 RESULT

• Sorelius K, Verhoek R, Berard X, Lyons OTA, Puges M, Wyss TR; International Expert Panel on Vascular Graft and Endograft Infections; European Society for Vascular Surgery Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections Writing Committee. Vascular Graft and Endograft Infections: A Delphi Consensus Document on Terminology, Definitions, Treatment, Outcomes, Follow Up, and Reporting Standards. Eur J Vasc Endovasc Surg. 2026 Mar;71(3):497-507. doi: 10.1016/j.ejvs.2025.07.044. Epub 2025 Jul 29.

  PMID: 40744353 RESULT

• Lejay A, Saleem BR, Barwick TD, Beck AW, Berard X, Eilenberg W, Gavali H, Hasse B, Heinola I, Lyons OT, Perini P, Puges M, Price NM, Sorelius K, Wouthuyzen-Bakker M, Wyss TR, Boyle J, Dias NV, van Herzeele I, Lepidi S, Mees BME, Resch T, Ribeiro TF, Trimarchi S, Wanhainen A, Chakfe N, Hernandez-Meneses M, Kahlberg A, Khashram M, Szeberin Z, Zeebregts C. Editor's Choice - European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections. Eur J Vasc Endovasc Surg. 2026 Aug;72(2):227-293. doi: 10.1016/j.ejvs.2026.05.035. Epub 2026 Jul 14.

  PMID: 42448560 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, serum, whole blood and/or leukocyte fractions, operative vascular tissue, vascular graft or endograft material, microbial isolates, and other clinically obtained specimens may be retained. Biospecimens will support studies of pathogen detection and liquid biopsy, prognostic biomarkers, microbial dynamics in fistula-associated infections, pathogen-specific investigations including Candida and mycobacteria, and in situ pathogen-host interactions. Serial specimens may be collected at diagnosis, during treatment, at surgery, and during follow-up when available.

MeSH Terms

Conditions

Mycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Qing Miao, MD, PhD

CONTACT

+8613917763967; miao.qing@zs-hospital.sh.cn

Jianing Yue, MD, PhD

CONTACT

yuejianing@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2036
• Study Completion (Estimated): November 1, 2041
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the main study results and available for 5 years.
• Access Criteria: Researchers may submit a scientifically sound proposal to the principal investigator. Requests will be reviewed based on scientific merit, feasibility, participant privacy, ethical approval, and applicable institutional and regulatory requirements. Approved researchers may be required to sign a data use agreement before access is granted.

Locations

CN (1)