Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-28 @ 3:36 AM
Study NCT ID:
NCT04152395
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Sponsor:
University of Thessaly
Organization:
Study Overview
Official Title:
Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: