Vascular Graft InfectionACHIEVENCT07696884
Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections
An observational study of Vascular Graft Infection and Vascular Endograft Infection, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Graft Infection, Vascular Endograft Infection, Aortic Graft Infection
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2024to 1 Sep 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of Clinical Outcomes and Host Immune Response to Vascular Graft and Endograft Infections
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.
- Keywords
- VGEI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start17 May 2024
- Primary completion1 Sep 2033 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Graft InfectionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Central Denmark Region, Randers Regional Hospital, Gødstrup Hospital, Regionshospitalet Horsens, University of Aarhus, Viborg Regional Hospital
- Responsible party
- Principal investigator, Rasmus Alstrup Nielsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696884
- Sponsor's protocol ID
- 1-10-72-114-23
- Acronym
- ACHIEVE
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcomes and Host Immune Response to Vascular Graft and Endograft Infections
- ClinicalTrials.gov ID
- NCT07696884
- Acronym / sponsor ID
- ACHIEVE / 1-10-72-114-23
- Keywords
- VGEI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University, Central Denmark Region, Randers Regional Hospital, Gødstrup Hospital, Regionshospitalet Horsens, University of Aarhus, Viborg Regional Hospital
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Sep 2033 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield
Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Graft Infection and Vascular Endograft Infection, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasmus A Nielsen, MD (+4522897999, raalni@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline (time frame: At baseline/inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.