NCT04254211

Brief Summary

This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

January 5, 2020

Last Update Submit

April 27, 2021

Conditions

Inflammation in EVAR

Outcome Measures

Primary Outcomes (6)

  • NLR major cardiovascular events (MACE)

    NLR indicator for major cardiovascular events (MACE)

    Day 4 postopertively

  • PLR major cardiovascular events (MACE)

    PLR indicator for major cardiovascular events (MACE)

    Day 4 postopertively

  • NLR acute kidney injury (AKI)

    NLR indicator for acute kidney injury (AKI)

    Day 4 postopertively

  • PLR acute kidney injury (AKI)

    PLR indicator for acute kidney injury (AKI)

    Day 4 postopertively

  • NLR death

    NLR indicator for death

    Day 4 postopertively

  • PLR death

    PLR indicator for death

    Day 4 postopertively

Study Arms (1)

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

Other: NLR

Interventions

NLROTHER

neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR)

Also known as: PLR
EVAR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included consecutive AAA patients treated electively by EVAR

You may qualify if:

  • AAA
  • Elective
  • EVAR

You may not qualify if:

  • Emergency
  • Open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Thessaly

Larissa, Thessaly, 41110, Greece

Location

Study Officials

  • Elena Arnaoutoglou, MD, PhD

    University of Thessaly

    STUDY CHAIR

  • Maria Ntalouka, MD

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

January 5, 2020

First Posted

February 5, 2020

Study Start

March 1, 2016

Primary Completion

February 1, 2019

Study Completion

November 1, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)