Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury

Completed

• Conditions: Ischemia Reperfusion Injury
• Interventions: Procedure: aorto-bifemoral bypass and aorta stentgraft

• Registration Number: NCT03397732
• Lead Sponsor: University of Pecs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2013-06-01
• Study Completion: 2013-06-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
• Over age 18
• agree to participate

Exclusion Criteria

• under age 18
• refuse to participate
• diagnosed malignant disease
• chronic steroid usage
• being on cytostatic therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aorto-bifemoral bypass	aorto-bifemoral bypass and aorta stentgraft	Patients scheduled for elective aorto-bifemoral bypass surgery by vascular surgeons and consented to participate in the study.
Aorta stentgraft	aorto-bifemoral bypass and aorta stentgraft	Patients scheduled for elective aorta stentgraft implantation by vascular surgeons and consented to participate in the study.

Primary Outcome Measures

Name	Time	Method
Perioperative time course of the MMP-9-TIMP-1 system	3 days	To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.

Secondary Outcome Measures

Name	Time	Method
MMP-9-TIMP-1 system and ischemia-reperfusion injury	3 days	To explore relationship between MMP-9-TIMP-1 system and vascular surgery related ischemia-reperfusion injury