Skip to content

Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04152395
Enrollment
220
Registered
2019-11-05
Start date
2020-06-01
Completion date
2022-12-11
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Endovascular Aortic Repair

Keywords

Metabolic Syndrome, EVAR

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.

Detailed description

Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without. Metabolic syndrome is defined by the definition of 2009 as: Increased waist circumflex (\>94 cm in men and \> 80 cm in women), increased triglycerides or in therapy, decreased HDL (\< 40 mg/dl in men and \<50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure\>130 mmHg or Diastolic Blood Pressure\>85 mmHg) or in therapy, increased fasting glucose (\>100mg/dl) or in therapy. All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.

Interventions

OTHEREVAR

Patients undergoing EVAR

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* elective EVAR

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysPatients after EVAR who died in 30 days

Secondary

MeasureTime frameDescription
Systematic inflammatory response30 daysPatients after EVAR that develop Systematic inflammatory response
Postimplantation syndrome30 daysPatients after EVAR that develop Postimplantation syndrome
Renal insufficiency30 daysPatients after EVAR that develop Renal insufficiency
Thromboembolic events30 daysIncidence of thromboembolic events in patients after EVAR
Complications of surgical procedure30 daysIncidence of Complications of surgical procedure
Cardiovascular events30 daysIncidence of cardiovascular events in patients after EVAR

Other

MeasureTime frameDescription
Postoperative delirium (POD)30 days, 6 and 12 monthsPrevalence of POD in patients undergoing EVAR

Contacts

Primary ContactKonstantina Kolonia, MD
kon.kolonia@gmail.com+306958261393
Backup ContactMetaxia Bareka, MD, PhD
barekametaxia@hotmail.com+306947845083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026