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

NCT01965717 | Completed

• 1 other identifier: KVEH KCS
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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 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

Keywords

endoleak; MMP- 9; biomarker

Outcome Measures

Primary Outcomes (1)

• Level of MMP 9

  The primary outcome measure is the serum levels of the MMP - 9 at twelve months after treatment

  12 months

Secondary Outcomes (1)

• Correlation of presence of endoleak and level of MMP 9

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with implantation of endovascular stent graft due to abdominal aortic aneurysm

You may qualify if:

• Patient fulfilling criteria for endovascular repair of infrarenal abdominal aortic aneurysm according to criteria of the participating centre.

Sponsors & Collaborators

• Igor Koncar: lead
• University of Genua, Italy: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre

Belgrade, 11000, Serbia

Location

Related Publications (4)

• Monaco M, Stassano P, Di Tommaso L, Iannelli G. Response of plasma matrix metalloproteinases and tissue inhibitor of metalloproteinases to stent-graft surgery for descending thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 2007 Oct;134(4):925-31. doi: 10.1016/j.jtcvs.2007.05.044.

  PMID: 17903509 BACKGROUND

• Lorelli DR, Jean-Claude JM, Fox CJ, Clyne J, Cambria RA, Seabrook GR, Towne JB. Response of plasma matrix metalloproteinase-9 to conventional abdominal aortic aneurysm repair or endovascular exclusion: implications for endoleak. J Vasc Surg. 2002 May;35(5):916-22. doi: 10.1067/mva.2002.123676.

  PMID: 12021707 BACKGROUND

• Sangiorgi G, D'Averio R, Mauriello A, Bondio M, Pontillo M, Castelvecchio S, Trimarchi S, Tolva V, Nano G, Rampoldi V, Spagnoli LG, Inglese L. Plasma levels of metalloproteinases-3 and -9 as markers of successful abdominal aortic aneurysm exclusion after endovascular graft treatment. Circulation. 2001 Sep 18;104(12 Suppl 1):I288-95. doi: 10.1161/hc37t1.094596.

  PMID: 11568071 BACKGROUND

• Hellenthal FA, Ten Bosch JA, Pulinx B, Wodzig WK, de Haan MW, Prins MH, Welten RJ, Teijink JA, Schurink GW. Plasma levels of matrix metalloproteinase-9: a possible diagnostic marker of successful endovascular aneurysm repair. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):171-2. doi: 10.1016/j.ejvs.2011.10.014. Epub 2011 Dec 14.

  PMID: 22172237 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood will be drawn via an antecubital vein puncture and collected in Heparin buffered vacutainer for plasma. Exactly 30 min after collection, blood will be centrifuged (15 min, 1000 g, 4C) and multiple aliquots will be stored at exactly 1 h after collection at \< - 20 C.

MeSH Terms

Conditions

Endoleak

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Lazar Davidovic, Prof

  Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vascular surgeon

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 18, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

SE (1)