Inflammation in EVARNCT04254211
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR
An observational study of Inflammation in EVAR, run by University of Thessaly at 1 site in Greece.
Trial summary
This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammation in EVAR
- What is being tested?
- NLR
- How many people
- 230 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2016to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included consecutive AAA patients treated electively by EVAR
Who may be able to join
- AAA
- Elective
- EVAR
Who cannot join
- Emergency
- Open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in Endovascular Aneurysm Repair for Abdominal Aorticaneurysm
This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.
Read the detailed description
The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.
- Conditions
- Inflammation in EVAR
- Being tested
- NLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NLROther
Also called PLR
neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR)
| Study group | Role | What they receive |
|---|---|---|
| EVAR | Patinets with AAA, treated electively by EVAR. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively. Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause Receives: Other: NLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
NLR major cardiovascular events (MACE)
NLR indicator for major cardiovascular events (MACE)
Measured: Day 4 postopertively
PLR major cardiovascular events (MACE)
PLR indicator for major cardiovascular events (MACE)
Measured: Day 4 postopertively
NLR acute kidney injury (AKI)
NLR indicator for acute kidney injury (AKI)
Measured: Day 4 postopertively
PLR acute kidney injury (AKI)
PLR indicator for acute kidney injury (AKI)
Measured: Day 4 postopertively
NLR death
NLR indicator for death
Measured: Day 4 postopertively
PLR death
PLR indicator for death
Measured: Day 4 postopertively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2016
- Primary completion1 Feb 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation in EVARStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Elena Arnaoutoglou, MD, PhD, Study chair, University of ThessalyMaria Ntalouka, MD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254211
- Sponsor's protocol ID
- NLR, PLR in EVAR
- Status last verified
- Apr 2021
- First submitted
- 5 Jan 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in Endovascular Aneurysm Repair for Abdominal Aorticaneurysm
- ClinicalTrials.gov ID
- NCT04254211
- Acronym / sponsor ID
- NLR, PLR in EVAR
- Conditions
- Inflammation in EVAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 5 Feb 2020 (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.
This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.
Detailed description
The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVAR | – | Other: NLRPatinets with AAA, treated electively by EVAR. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively. Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included consecutive AAA patients treated electively by EVAR
Key inclusion criteria (3 listed)
- AAA
- Elective
- EVAR
Key exclusion criteria (2 listed)
- Emergency
- Open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NLRAlso: PLRneutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) | Other | EVAR |
Primary outcome
NLR major cardiovascular events (MACE)
Time frame: Day 4 postopertively
NLR indicator for major cardiovascular events (MACE)
PLR major cardiovascular events (MACE)
Time frame: Day 4 postopertively
PLR indicator for major cardiovascular events (MACE)
NLR acute kidney injury (AKI)
Time frame: Day 4 postopertively
NLR indicator for acute kidney injury (AKI)
PLR acute kidney injury (AKI)
Time frame: Day 4 postopertively
PLR indicator for acute kidney injury (AKI)
NLR death
Time frame: Day 4 postopertively
NLR indicator for death
PLR death
Time frame: Day 4 postopertively
PLR indicator for death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Elena Arnaoutoglou, MD, PhD study chair
University of Thessaly
Maria Ntalouka, MD principal investigator
University Hospital of Larissa
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 Inflammation in EVAR, run by University of Thessaly at 1 site in Greece.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2021. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NLR major cardiovascular events (MACE) (time frame: Day 4 postopertively). The study lists 6 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 28 Apr 2021.