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

NCT07696884 | Recruiting

• 1 other identifier: 1-10-72-114-23
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Graft Infection; Vascular Endograft Infection; Aortic Graft Infection

Keywords

VGEI

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield

  At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

Other Outcomes (1)

• Distribution of microbiological pathogens identified in VGEI participants

  From inclusion through follow-up, up to 10 years

Study Arms (3)

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

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viborg Regional Hospital: collaborator
• Aalborg University: collaborator
• Central Denmark Region: collaborator
• Randers Regional Hospital: collaborator
• Gødstrup Hospital: collaborator
• Regionshospitalet Horsens: collaborator
• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma/serum, whole blood/PAXgene DNA/RNA, PBMCs; clinical isolates and explanted graft/perigraft material when available and separately consented.

Central Study Contacts

Rasmus A Nielsen, MD

CONTACT

+4522897999; raalni@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: May 17, 2024
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)