Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-04-05 @ 8:23 AM
Study NCT ID:
NCT03397732
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2018-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2018-01-06', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative time course of the MMP-9-TIMP-1 system', 'timeFrame': '3 days', 'description': 'To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.'}], 'secondaryOutcomes': [{'measure': 'MMP-9-TIMP-1 system and ischemia-reperfusion injury', 'timeFrame': '3 days', 'description': 'To explore relationship between MMP-9-TIMP-1 system and vascular surgery related ischemia-reperfusion injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Matrix metalloproteinase', 'Tissue inhibitor of matrix metalloproteinase', 'Vascular surgery', 'Aorta stent implantation', 'Aorto-bifemoral bypass surgery'], 'conditions': ['Ischemia Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '25155253', 'type': 'RESULT', 'citation': 'Nagy B, Szelig L, Rendeki S, Loibl C, Rezman B, Lantos J, Bogar L, Csontos C. Dynamic changes of matrix metalloproteinase 9 and tissue inhibitor of metalloproteinase 1 after burn injury. J Crit Care. 2015 Feb;30(1):162-6. doi: 10.1016/j.jcrc.2014.07.008. Epub 2014 Jul 11.'}, {'pmid': '21530151', 'type': 'RESULT', 'citation': 'Muhl D, Nagy B, Woth G, Falusi B, Bogar L, Weber G, Lantos J. Dynamic changes of matrix metalloproteinases and their tissue inhibitors in severe sepsis. J Crit Care. 2011 Dec;26(6):550-5. doi: 10.1016/j.jcrc.2011.02.011. Epub 2011 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R\\&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed atherosclerotic and/or aorta aneurysma generaly associated with hypertension and diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.\n* Over age 18\n* agree to participate\n\nExclusion Criteria:\n\n* under age 18\n* refuse to participate\n* diagnosed malignant disease\n* chronic steroid usage\n* being on cytostatic therapy'}, 'identificationModule': {'nctId': 'NCT03397732', 'briefTitle': 'Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury', 'orgStudyIdInfo': {'id': '4330'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aorto-bifemoral bypass', 'description': 'Patients scheduled for elective aorto-bifemoral bypass surgery by vascular surgeons and consented to participate in the study.', 'interventionNames': ['Procedure: aorto-bifemoral bypass and aorta stentgraft']}, {'label': 'Aorta stentgraft', 'description': 'Patients scheduled for elective aorta stentgraft implantation by vascular surgeons and consented to participate in the study.', 'interventionNames': ['Procedure: aorto-bifemoral bypass and aorta stentgraft']}], 'interventions': [{'name': 'aorto-bifemoral bypass and aorta stentgraft', 'type': 'PROCEDURE', 'description': 'Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.', 'armGroupLabels': ['Aorta stentgraft', 'Aorto-bifemoral bypass']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Diána Mühl, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pécs, Dept. of Anaesthesia and Intensive Care Pécs, Baranya county, Hungary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gábor László Woth', 'investigatorAffiliation': 'University of Pecs'}}}}