Multicentre Trial Of Serum Levels Of MMP-9 As A Biomarker Of Endoleak
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Level of MMP 9
研究概览
简要总结
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
详细描述
- 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 technical success of the procedure will provide subgroup of patients with higher correlation between the aneurysm exclusion and serum level of MMP -9. The primary outcome measure is the serum levels of the MMP - 9 at one, six and twelve months after treatment and its relation with anatomical, demographic and procedure related data. Clinical outcome events include different types of endoleak. The secondary outcome is the correlation of different types of endoleak with the serum levels of the MMP - 9.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient fulfilling criteria for endovascular repair of infrarenal abdominal aortic aneurysm according to criteria of the participating centre.
排除标准
- •Already performed endovascular aneurysm exclusion with unknown baseline levels of MMP-9; presence of aneurysm in other location; usage of MMP-9 inhibiting drugs (tetraciklincs); presence of active malignant disease;
结局指标
主要结局
Level of MMP 9
时间窗: 12 months
The primary outcome measure is the serum levels of the MMP - 9 at twelve months after treatment
次要结局
- Correlation of presence of endoleak and level of MMP 9(12 months)
研究者
Igor Koncar
vascular surgeon
University of Belgrade