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Clinical Trials in Denmark / NCT07696884
Recruiting Observational

Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections

NCT07696884 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Observational
Started
2024-05-17
Last updated
2026-07-10

Condition(s) studied

Vascular Graft InfectionVascular Endograft InfectionAortic Graft Infection

Study summary

ACHIEVE is a prospective observational cohort and biobank study of patients with suspected or diagnosed central vascular graft or endograft infection. The study also includes patients undergoing elective central vascular graft or endograft implantation and healthy blood donor controls. Participants undergo longitudinal clinical data collection and biospecimen sampling. The study aims to characterize clinical outcomes, host immune responses, inflammatory biomarkers, pathogen-related factors, and novel microbiological diagnostic methods, including microbial cell-free DNA sequencing, in vascular graft and endograft infections.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age 18 years or older. * Able and willing to provide informed consent. * For the vascular graft or endograft infection group: suspected or diagnosed vascular graft or endograft infection in a central vascular prosthesis as determined by the treating clinicians. * For the elective vascular graft or endograft control group: planned central vascular graft or endograft implantation. * For the healthy blood donor control group: active blood donor registered at Aarhus University Hospital Blood Bank. * For the healthy blood donor control group: no current infection or other active disease. Exclusion Criteria: * For the elective vascular graft or endograft control group: surgery performed as an emergency procedure within 24 hours. * For the elective vascular graft or endograft control group: reoperation of a previously implanted vascular graft or endograft. * For the elective vascular graft or endograft control group: evidence suggestive of ongoing infection in the area of surgery. * Unable to provide informed consent.

Primary outcome measure(s)

  • Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline — At baseline/inclusion
    Percentage of live PBMCs identified as myeloid-derived suppressor cells by flow cytometry, compared between participants with vascular graft or endograft infection and elective vascular graft/endograft controls.
  • Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity — At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
    Selected VGEI sampling events with final consensus sample-level mNGS result classified as positive divided by all selected VGEI sampling events within the predefined clinical sampling category.
  • Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity — At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
    Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07696884 on ClinicalTrials.gov ↗ ← All trials in Denmark