Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
May 25, 2020 updated by: Elena Arnaoutoglou, University of Thessaly
Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients scheduled for elective EVAR
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Metabolic group
Patients with metabolic syndrome undergoing EVAR
|
Patients undergoing EVAR
|
|
Control group
Patients without metabolic syndrome undergoing EVAR
|
Patients undergoing EVAR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 30 days
|
Patients after EVAR who died in 30 days
|
30 days
|
|
Mortality
Time Frame: 6 months
|
Patients after EVAR who died in 6 months
|
6 months
|
|
Mortality
Time Frame: 12 months
|
Patients after EVAR who died in 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systematic inflammatory response
Time Frame: 30 days
|
Patients after EVAR that develop Systematic inflammatory response
|
30 days
|
|
Systematic inflammatory response
Time Frame: 6 months
|
Patients after EVAR that develop Systematic inflammatory response
|
6 months
|
|
Systematic inflammatory response
Time Frame: 12 months
|
Patients after EVAR that develop Systematic inflammatory response
|
12 months
|
|
Postimplantation syndrome
Time Frame: 30 days
|
Patients after EVAR that develop Postimplantation syndrome
|
30 days
|
|
Postimplantation syndrome
Time Frame: 6 months
|
Patients after EVAR that develop Postimplantation syndrome
|
6 months
|
|
Postimplantation syndrome
Time Frame: 12 months
|
Patients after EVAR that develop Postimplantation syndrome
|
12 months
|
|
Renal insufficiency
Time Frame: 30 days
|
Patients after EVAR that develop Renal insufficiency
|
30 days
|
|
Renal insufficiency
Time Frame: 6 months
|
Patients after EVAR that develop Renal insufficiency
|
6 months
|
|
Renal insufficiency
Time Frame: 12 months
|
Patients after EVAR that develop Renal insufficiency
|
12 months
|
|
Cardiovascular events
Time Frame: 30 days
|
Incidence of cardiovascular events in patients after EVAR
|
30 days
|
|
Cardiovascular events
Time Frame: 6 months
|
Incidence of cardiovascular events in patients after EVAR
|
6 months
|
|
Cardiovascular events
Time Frame: 12 months
|
Incidence of cardiovascular events in patients after EVAR
|
12 months
|
|
Thromboembolic events
Time Frame: 30 days
|
Incidence of thromboembolic events in patients after EVAR
|
30 days
|
|
Thromboembolic events
Time Frame: 6 months
|
Incidence of thromboembolic events in patients after EVAR
|
6 months
|
|
Thromboembolic events
Time Frame: 12 months
|
Incidence of thromboembolic events in patients after EVAR
|
12 months
|
|
Complications of surgical procedure
Time Frame: 30 days
|
Incidence of Complications of surgical procedure
|
30 days
|
|
Complications of surgical procedure
Time Frame: 6 months
|
Incidence of Complications of surgical procedure
|
6 months
|
|
Complications of surgical procedure
Time Frame: 12 months
|
Incidence of Complications of surgical procedure
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative delirium (POD)
Time Frame: 30 days, 6 and 12 months
|
Prevalence of POD in patients undergoing EVAR
|
30 days, 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Haralampos Milionis, MD, PhD, University of Ioannina
- Principal Investigator: Konstantina Kolonia, MD, PhD, University Hospital of Larissa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
December 11, 2021
Study Completion (Anticipated)
December 11, 2022
Study Registration Dates
First Submitted
September 24, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 5, 2019
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 25, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Metabolic syndrome in EVAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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