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Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

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ClinicalTrials.gov Identifier: NCT04152395
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, 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.

Condition or disease Intervention/treatment
Metabolic Syndrome Endovascular Aortic Repair Other: EVAR

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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 11, 2021
Estimated Study Completion Date : December 11, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Metabolic group
Patients with metabolic syndrome undergoing EVAR
Other: EVAR
Patients undergoing EVAR

Control group
Patients without metabolic syndrome undergoing EVAR
Other: EVAR
Patients undergoing EVAR




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Patients after EVAR who died in 30 days

  2. Mortality [ Time Frame: 6 months ]
    Patients after EVAR who died in 6 months

  3. Mortality [ Time Frame: 12 months ]
    Patients after EVAR who died in 12 months


Secondary Outcome Measures :
  1. Systematic inflammatory response [ Time Frame: 30 days ]
    Patients after EVAR that develop Systematic inflammatory response

  2. Systematic inflammatory response [ Time Frame: 6 months ]
    Patients after EVAR that develop Systematic inflammatory response

  3. Systematic inflammatory response [ Time Frame: 12 months ]
    Patients after EVAR that develop Systematic inflammatory response

  4. Postimplantation syndrome [ Time Frame: 30 days ]
    Patients after EVAR that develop Postimplantation syndrome

  5. Postimplantation syndrome [ Time Frame: 6 months ]
    Patients after EVAR that develop Postimplantation syndrome

  6. Postimplantation syndrome [ Time Frame: 12 months ]
    Patients after EVAR that develop Postimplantation syndrome

  7. Renal insufficiency [ Time Frame: 30 days ]
    Patients after EVAR that develop Renal insufficiency

  8. Renal insufficiency [ Time Frame: 6 months ]
    Patients after EVAR that develop Renal insufficiency

  9. Renal insufficiency [ Time Frame: 12 months ]
    Patients after EVAR that develop Renal insufficiency

  10. Cardiovascular events [ Time Frame: 30 days ]
    Incidence of cardiovascular events in patients after EVAR

  11. Cardiovascular events [ Time Frame: 6 months ]
    Incidence of cardiovascular events in patients after EVAR

  12. Cardiovascular events [ Time Frame: 12 months ]
    Incidence of cardiovascular events in patients after EVAR

  13. Thromboembolic events [ Time Frame: 30 days ]
    Incidence of thromboembolic events in patients after EVAR

  14. Thromboembolic events [ Time Frame: 6 months ]
    Incidence of thromboembolic events in patients after EVAR

  15. Thromboembolic events [ Time Frame: 12 months ]
    Incidence of thromboembolic events in patients after EVAR

  16. Complications of surgical procedure [ Time Frame: 30 days ]
    Incidence of Complications of surgical procedure

  17. Complications of surgical procedure [ Time Frame: 6 months ]
    Incidence of Complications of surgical procedure

  18. Complications of surgical procedure [ Time Frame: 12 months ]
    Incidence of Complications of surgical procedure


Other Outcome Measures:
  1. Postoperative delirium (POD) [ Time Frame: 30 days, 6 and 12 months ]
    Prevalence of POD in patients undergoing EVAR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for elective EVAR
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152395


Contacts
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Contact: Konstantina Kolonia, MD +306958261393 kon.kolonia@gmail.com
Contact: Metaxia Bareka, MD, PhD +306947845083 barekametaxia@hotmail.com

Sponsors and Collaborators
University of Thessaly
Investigators
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Study Chair: Elena Arnaoutoglou, MD, PhD University of Thessaly
Study Director: Haralampos Milionis, MD, PhD University of Ioannina
Principal Investigator: Konstantina Kolonia, MD, PhD University Hospital of Larissa
Publications of Results:
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.

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Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT04152395    
Other Study ID Numbers: Metabolic syndrome in EVAR
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Arnaoutoglou, University of Thessaly:
Metabolic Syndrome
EVAR
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases