Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04152395
• Other study ID #: Metabolic syndrome in EVAR
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: December 11, 2022

Study information

• Verified date: May 2020
• Source: University of Thessaly
• Contact: Konstantina Kolonia, MD
• Phone: +306958261393
• Email: kon.kolonia[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 11, 2022
• Est. primary completion date: December 11, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Aortic Repair
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• EVAR
Patients undergoing EVAR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

References & Publications (4)

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. — View Citation

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 Associa — View Citation

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. — View Citation

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 Bloo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative delirium (POD)	Prevalence of POD in patients undergoing EVAR	30 days, 6 and 12 months
Primary	Mortality	Patients after EVAR who died in 30 days	30 days
Primary	Mortality	Patients after EVAR who died in 6 months	6 months
Primary	Mortality	Patients after EVAR who died in 12 months	12 months
Secondary	Systematic inflammatory response	Patients after EVAR that develop Systematic inflammatory response	30 days
Secondary	Systematic inflammatory response	Patients after EVAR that develop Systematic inflammatory response	6 months
Secondary	Systematic inflammatory response	Patients after EVAR that develop Systematic inflammatory response	12 months
Secondary	Postimplantation syndrome	Patients after EVAR that develop Postimplantation syndrome	30 days
Secondary	Postimplantation syndrome	Patients after EVAR that develop Postimplantation syndrome	6 months
Secondary	Postimplantation syndrome	Patients after EVAR that develop Postimplantation syndrome	12 months
Secondary	Renal insufficiency	Patients after EVAR that develop Renal insufficiency	30 days
Secondary	Renal insufficiency	Patients after EVAR that develop Renal insufficiency	6 months
Secondary	Renal insufficiency	Patients after EVAR that develop Renal insufficiency	12 months
Secondary	Cardiovascular events	Incidence of cardiovascular events in patients after EVAR	30 days
Secondary	Cardiovascular events	Incidence of cardiovascular events in patients after EVAR	6 months
Secondary	Cardiovascular events	Incidence of cardiovascular events in patients after EVAR	12 months
Secondary	Thromboembolic events	Incidence of thromboembolic events in patients after EVAR	30 days
Secondary	Thromboembolic events	Incidence of thromboembolic events in patients after EVAR	6 months
Secondary	Thromboembolic events	Incidence of thromboembolic events in patients after EVAR	12 months
Secondary	Complications of surgical procedure	Incidence of Complications of surgical procedure	30 days
Secondary	Complications of surgical procedure	Incidence of Complications of surgical procedure	6 months
Secondary	Complications of surgical procedure	Incidence of Complications of surgical procedure	12 months