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| Name | Class |
|---|---|
| Aalborg University | OTHER |
| Central Denmark Region | OTHER |
| Randers Regional Hospital | OTHER |
| Gødstrup Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Patients with diagnosed or suspected central/intracavitary vascular graft or endograft infection (VGEI) | ||
| Control group | Patients without infection planned for elective implantation of a central/intracavitary vascular graft or endograft | ||
| Healthy Blood Donors | Healthy Blood Donors |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline | 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. | At baseline/inclusion |
| Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity | 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. | At each paired VGEI sampling event from inclusion through follow-up, up to 10 years |
| Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity | Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category. | At each paired VGEI sampling event from inclusion through follow-up, up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield | Selected VGEI sampling events with consensus sample-level mNGS positivity and negative paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category. | At each paired VGEI sampling event from inclusion through follow-up, up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of microbiological pathogens identified in VGEI participants | Type of microorganism identified by conventional microbiology from blood, perioperative specimens, operative wounds, graft/perigraft material, or other clinically relevant foci in enrolled VGEI participants. | From inclusion through follow-up, up to 10 years |
Inclusion Criteria:
Exclusion Criteria:
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Study participants will be selected from clinical populations in the Central Denmark Region. Patients with suspected or diagnosed central vascular graft or endograft infection will be identified through infectious diseases and vascular/cardiothoracic surgical clinical care pathways, electronic medical records, and local departmental databases. Elective vascular graft/endograft control participants will be identified through the preoperative surgical pathway. Healthy blood donor controls will be selected from the Aarhus University Hospital Blood Bank during routine blood donation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rasmus A Nielsen, MD | Contact | +4522897999 | raalni@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
No individual participant data will be made publicly available. The study includes a rare patient population and detailed clinical, microbiological, imaging, biomarker, and biospecimen-derived data, which may carry a risk of participant re-identification even after de-identification. Data will be stored and processed in accordance with the Danish Data Protection Act and the General Data Protection Regulation. Aggregated study results will be published in peer-reviewed journals.
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| OTHER |
| Regionshospitalet Horsens | OTHER |
| University of Aarhus | OTHER |
| Viborg Regional Hospital | OTHER |
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Blood, plasma/serum, whole blood/PAXgene DNA/RNA, PBMCs; clinical isolates and explanted graft/perigraft material when available and separately consented.