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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative delirium (POD)', 'timeFrame': '30 days, 6 and 12 months', 'description': 'Prevalence of POD in patients undergoing EVAR'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Patients after EVAR who died in 30 days'}, {'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'Patients after EVAR who died in 6 months'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'Patients after EVAR who died in 12 months'}], 'secondaryOutcomes': [{'measure': 'Systematic inflammatory response', 'timeFrame': '30 days', 'description': 'Patients after EVAR that develop Systematic inflammatory response'}, {'measure': 'Systematic inflammatory response', 'timeFrame': '6 months', 'description': 'Patients after EVAR that develop Systematic inflammatory response'}, {'measure': 'Systematic inflammatory response', 'timeFrame': '12 months', 'description': 'Patients after EVAR that develop Systematic inflammatory response'}, {'measure': 'Postimplantation syndrome', 'timeFrame': '30 days', 'description': 'Patients after EVAR that develop Postimplantation syndrome'}, {'measure': 'Postimplantation syndrome', 'timeFrame': '6 months', 'description': 'Patients after EVAR that develop Postimplantation syndrome'}, {'measure': 'Postimplantation syndrome', 'timeFrame': '12 months', 'description': 'Patients after EVAR that develop Postimplantation syndrome'}, {'measure': 'Renal insufficiency', 'timeFrame': '30 days', 'description': 'Patients after EVAR that develop Renal insufficiency'}, {'measure': 'Renal insufficiency', 'timeFrame': '6 months', 'description': 'Patients after EVAR that develop Renal insufficiency'}, {'measure': 'Renal insufficiency', 'timeFrame': '12 months', 'description': 'Patients after EVAR that develop Renal insufficiency'}, {'measure': 'Cardiovascular events', 'timeFrame': '30 days', 'description': 'Incidence of cardiovascular events in patients after EVAR'}, {'measure': 'Cardiovascular events', 'timeFrame': '6 months', 'description': 'Incidence of cardiovascular events in patients after EVAR'}, {'measure': 'Cardiovascular events', 'timeFrame': '12 months', 'description': 'Incidence of cardiovascular events in patients after EVAR'}, {'measure': 'Thromboembolic events', 'timeFrame': '30 days', 'description': 'Incidence of thromboembolic events in patients after EVAR'}, {'measure': 'Thromboembolic events', 'timeFrame': '6 months', 'description': 'Incidence of thromboembolic events in patients after EVAR'}, {'measure': 'Thromboembolic events', 'timeFrame': '12 months', 'description': 'Incidence of thromboembolic events in patients after EVAR'}, {'measure': 'Complications of surgical procedure', 'timeFrame': '30 days', 'description': 'Incidence of Complications of surgical procedure'}, {'measure': 'Complications of surgical procedure', 'timeFrame': '6 months', 'description': 'Incidence of Complications of surgical procedure'}, {'measure': 'Complications of surgical procedure', 'timeFrame': '12 months', 'description': 'Incidence of Complications of surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'EVAR'], 'conditions': ['Metabolic Syndrome', 'Endovascular Aortic Repair']}, 'referencesModule': {'references': [{'pmid': '19805654', 'type': 'RESULT', '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.'}, {'pmid': '16182882', 'type': 'RESULT', '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.'}, {'pmid': '18340209', 'type': 'RESULT', '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.'}, {'pmid': '25988468', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without.\n\nMetabolic syndrome is defined by the definition of 2009 as:\n\nIncreased 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients scheduled for elective EVAR', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective EVAR\n\nExclusion Criteria:\n\n* Patients incapable to give informed consent\n* Pregnancy\n* Cancer\n* Systematic Inflammatory disease\n* Use of steroids\n* Emergency surgery\n* Prior ICU admission'}, 'identificationModule': {'nctId': 'NCT04152395', 'briefTitle': 'Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)', 'orgStudyIdInfo': {'id': 'Metabolic syndrome in EVAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metabolic group', 'description': 'Patients with metabolic syndrome undergoing EVAR', 'interventionNames': ['Other: EVAR']}, {'label': 'Control group', 'description': 'Patients without metabolic syndrome undergoing EVAR', 'interventionNames': ['Other: EVAR']}], 'interventions': [{'name': 'EVAR', 'type': 'OTHER', 'description': 'Patients undergoing EVAR', 'armGroupLabels': ['Control group', 'Metabolic group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Konstantina Kolonia, MD', 'role': 'CONTACT', 'email': 'kon.kolonia@gmail.com', 'phone': '+306958261393'}, {'name': 'Metaxia Bareka, MD, PhD', 'role': 'CONTACT', 'email': 'barekametaxia@hotmail.com', 'phone': '+306947845083'}], 'overallOfficials': [{'name': 'Elena Arnaoutoglou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly'}, {'name': 'Haralampos Milionis, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Ioannina'}, {'name': 'Konstantina Kolonia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Larissa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Elena Arnaoutoglou', 'investigatorAffiliation': 'University of Thessaly'}}}}