Clinical trial NCT04152395: Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Official title: Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Endovascular Aortic Repair
Keywords: Metabolic Syndrome
EVAR
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 6 months
measure: Mortality
timeFrame: 12 months
Secondary outcomes:
measure: Systematic inflammatory response
timeFrame: 30 days
measure: Systematic inflammatory response
timeFrame: 6 months
measure: Systematic inflammatory response
timeFrame: 12 months
measure: Postimplantation syndrome
timeFrame: 30 days
measure: Postimplantation syndrome
timeFrame: 6 months
measure: Postimplantation syndrome
timeFrame: 12 months
measure: Renal insufficiency
timeFrame: 30 days
measure: Renal insufficiency
timeFrame: 6 months
measure: Renal insufficiency
timeFrame: 12 months
measure: Cardiovascular events
timeFrame: 30 days
measure: Cardiovascular events
timeFrame: 6 months
measure: Cardiovascular events
timeFrame: 12 months
measure: Thromboembolic events
timeFrame: 30 days
measure: Thromboembolic events
timeFrame: 6 months
measure: Thromboembolic events
timeFrame: 12 months
measure: Complications of surgical procedure
timeFrame: 30 days
measure: Complications of surgical procedure
timeFrame: 6 months
measure: Complications of surgical procedure
timeFrame: 12 months
Other outcomes:
measure: Postoperative delirium (POD)
timeFrame: 30 days, 6 and 12 months
Locations:
Study officials:
affiliation: University of Thessaly
name: Elena Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University of Ioannina
name: Haralampos Milionis, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Konstantina Kolonia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 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.
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. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
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 Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
citation: 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.