NCT04152395

Brief Summary

This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

September 24, 2019

Last Update Submit

May 25, 2020

Conditions

Metabolic SyndromeEndovascular Aortic Repair

Keywords

Metabolic SyndromeEVAR

Outcome Measures

Primary Outcomes (3)

  • Mortality

    Patients after EVAR who died in 30 days

    30 days

  • Mortality

    Patients after EVAR who died in 6 months

    6 months

  • Mortality

    Patients after EVAR who died in 12 months

    12 months

Secondary Outcomes (18)

  • Systematic inflammatory response

    30 days

  • Systematic inflammatory response

    6 months

  • Systematic inflammatory response

    12 months

  • Postimplantation syndrome

    30 days

  • Postimplantation syndrome

    6 months

  • +13 more secondary outcomes

Other Outcomes (1)

  • Postoperative delirium (POD)

    30 days, 6 and 12 months

Study Arms (2)

Metabolic group

Patients with metabolic syndrome undergoing EVAR

Other: EVAR

Control group

Patients without metabolic syndrome undergoing EVAR

Other: EVAR

Interventions

EVAROTHER

Patients undergoing EVAR

Control groupMetabolic group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for elective EVAR

You may qualify if:

  • elective EVAR

You may not qualify if:

  • Patients incapable to give informed consent
  • Pregnancy
  • Cancer
  • Systematic Inflammatory disease
  • Use of steroids
  • Emergency surgery
  • Prior ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

    PMID: 19805654RESULT

  • Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.

    PMID: 16182882RESULT

  • Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.

    PMID: 18340209RESULT

  • Aguilar M, Bhuket T, Torres S, Liu B, Wong RJ. Prevalence of the metabolic syndrome in the United States, 2003-2012. JAMA. 2015 May 19;313(19):1973-4. doi: 10.1001/jama.2015.4260. No abstract available.

    PMID: 25988468RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Elena Arnaoutoglou, MD, PhD

    University of Thessaly

    STUDY CHAIR

  • Haralampos Milionis, MD, PhD

    University of Ioannina

    STUDY DIRECTOR

  • Konstantina Kolonia, MD, PhD

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantina Kolonia, MD

CONTACT

+306958261393kon.kolonia@gmail.com

Metaxia Bareka, MD, PhD

CONTACT

+306947845083barekametaxia@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

September 24, 2019

First Posted

November 5, 2019

Study Start

June 1, 2020

Primary Completion

December 11, 2021

Study Completion

December 11, 2022

Last Updated

May 27, 2020

Record last verified: 2020-05