Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

• Conditions: Metabolic Syndrome; Endovascular Aortic Repair
• Interventions: Other: EVAR

• Registration Number: NCT04152395
• Lead Sponsor: University of Thessaly

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.

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27
• Study Start: 2020-06-01
• Primary Completion: 2021-12-11
• Study Completion: 2022-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metabolic group	EVAR	Patients with metabolic syndrome undergoing EVAR
Control group	EVAR	Patients without metabolic syndrome undergoing EVAR

Primary Outcome Measures

Name	Time	Method
Mortality	12 months	Patients after EVAR who died in 12 months

Secondary Outcome Measures

Name	Time	Method
Systematic inflammatory response	12 months	Patients after EVAR that develop Systematic inflammatory response
Postimplantation syndrome	12 months	Patients after EVAR that develop Postimplantation syndrome
Renal insufficiency	12 months	Patients after EVAR that develop Renal insufficiency
Cardiovascular events	12 months	Incidence of cardiovascular events in patients after EVAR
Thromboembolic events	12 months	Incidence of thromboembolic events in patients after EVAR
Complications of surgical procedure	12 months	Incidence of Complications of surgical procedure