Clinical Trial: Multicentre Trial Of Serum Levels Of MMP-9 As A Biomarker Of Endoleak
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title:
Brief Summary:
Endovascular procedures already brought enormous revolution in the process of treatment of patient with abdominal aortic aneurysm (AAA). It is well defined that early mortality and morbidity is significantly reduced comparing to open repair. The persistent concern is long term durability of devices and their success of aneurysm exclusion in order to prevent rupture. At the moment the best armament to prevent rupture after endovascular exclusion is the watchful waiting and timely reintervention. The main complication that follows this procedure and causing catastrophic long term complications is endoleak. The ideal algorithm to follow up patients after aneurysm exclusion has not been found. In order to reveal endoleak ultrasound is used more than before, however frequent computerized tomography is wasting a lot of costs and exposing patients to irradiation and nephrotoxic contrast.
Matrix metalloproteinase activity has been demonstrated in the process of aneurysm development. Imbalance between MMP and its inhibitors TIMP provokes collagenolytic and elastolytic activity that is inducing aneurysmatic degeneration of aortic wall. Due to the previously described connection between aneurysm and MMP activity, it was proved that serum level of MMP-9 is significantly higher in patients with abdominal aortic aneurysm (AAA). Also, higher levels of MMP-9 were discovered in patients with inadequate aneurysm exclusion after endovascular procedure suggesting that degradation of the aortic wall is still ongoing process, not being the case with successfully excluded aneurysm. There might be a potential role of MMP-9 serum level as a biomarker of present endoleak after endovascular aneurysm exclusion.
All published trials have shown correlation between MMP 9 activity and presence of endoleak, however, no correlation was made between specifi
Detailed Summary:
-
Summary
Endovascular aortic aneurysm repair (EVAR) provides low early mortality and requires intensive follow up of the patients in order to prevent rupture as a consequence of endoleak. Follow up protocols are changing with time differing between the hospitals and even the physicians. Ultrasonography (US), contrast enhanced ultrasonography, multisliced computed tomography (MSCT) and native radiography are most frequently used. All these techniques are combined in order to compensate their lacks and disadvantages. The new methods for early detection of endoleak should improve this cumbersome follow up process.
Matrix metalloproteinase (MMP) activity has been demonstrated in the process of aneurysm development. Higher level of MMP-9 were discovered in patients with inadequate aneurysm exclusion after endovascular procedure suggests that degradation of the aortic wall is still ongoing process and that there might be a potential role of MMP-9 serum level as a biomarker in endoleak detection.
Aim of this study is to explore the serum levels of MMP - 9 in patients treated with endovascular aneurysm repair and to provide some more profound information regarding its' correlation with different types of endoleak.
Patients treated with EVAR will be followed for at least one year. During five visits, with first preoperative, then on discharge, and after one, six and twelve months, patients will be examined by means of US and MSCT. During the same five visits serum levels of MMP -9 will be measured and correlated with different levels of aneurysm exclusion. Collected anatomical, demographic data of the patients and intraoperative data related to the technica
Sponsor: Igor Koncar
Current Primary Outcome: Level of MMP 9 [ Time Frame: 12 months ]
The primary outcome measure is the serum levels of the MMP - 9 at twelve months after treatment
Original Primary Outcome: Same as current
Current Secondary Outcome: Correlation of presence of endoleak and level of MMP 9 [ Time Frame: 12 months ]
The secondary outcome measure is the correlation between the serum levels of the MMP - 9 at twelve months after treatment and presence of endoleak
Original Secondary Outcome: Same as current
Information By: University of Belgrade
Dates:
Date Received: October 15, 2013
Date Started: July 2012
Date Completion: December 2020
Last Updated: February 24, 2015
Last Verified: February 2015
