Multicentre Trial Of Serum Levels Of MMP-9 As A Biomarker Of Endoleak

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 specific types of endoleak and necessity to reoperation (clinical significance). Additionally there were only four trials presented in the literature investigating low number of patients.

Since there is possible value of MMP-9 serum level as biomarker of present endoleak, further studies are necessary. This why we are organizing multicentre trial, that will cover significant number of patients in order to define

* Value of MMP-9 as a biomarker of successful initial exclusion
* Value of MMP-9 level as predictor of aneurysm shrinkage
* Value of MMP-9 level in patients with increased aneurysm diameter and no visible endoleak
* Correlation of the MMP -9 serum level with different type of enoleak
* Value of MMP-9 as biomarker of successful treatment of endoelak

Material and methods Patient with AAA greater then 55 mm in diameter that are candidates for endovascular repair will be selected. Demographic, anatomical and data regarding the procedure will be gathered prospectively. Also serum levels of MMP-9 will be measured before procedure, during the first week before discharge, and after 1,6,12,18,24,36,48 months. On the same day of measuring MMP-9 level control MSCT and ultrasonography exam will be performed in order to collect data regarding the success of exclusion and presence of any endoleak with the accurate measurement of aneurysm diameter changes. Ultrasonography and MSCT exam will be performed by experienced physicians, also preoperative evaluation of anatomical data.

In case of reintervention additional questionnaire will be filled regarding anatomical and procedure related data using pre and postoperative ultrasound and MSCT examination, while MMP-9 levels will be measured before procedure and after the procedure using the same protocol as for primary procedure.

Statistical analysys Levels of MMP-9 in serum with presence of different types of endoleak will be correlated one week and 1,6,12,18,24,36 48 months after the procedure Anatomical data will be correlated with the decrease in MMP-9 level before and after procedure Levels of MMP-9 in serum after one week and one month will be correlated with further aneurysm shrinkage Level of MMP-9 in serum with type of endoleak will be correlated Level of MMP-9 before and after reoperation will be compared Level of MMp-9 in serum of patients with disappearing endoleaks will be followed Level of MMP-9 in serum of patients with new endoleaks will be followed

Conditions

• Endoleak After Endovascular Aneurysm Repair

Sponsors & Collaborators

• Uniuversity of Genua, Italy

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• Igor Koncar

  lead OTHER

Principal Investigators

• Lazar Davidovic, Prof · Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2016-12-31

Completion

2017-12-31

Countries

• Serbia

Study Locations