Influence of Statins in Artery Aneurysms

NCT03061487 | Unknown DMC

• 1 other identifier: ER.ALL.2016.04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of proteolytic enzymes that along with their specific and non-specific inhibitors modulate the extracellular matrix composition. Recent studies have suggested an interesting role of microRNAs (miRNAs) in the regulation mechanisms of inflammation. The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.

Conditions

Statin; Aneurysm; Extracellular Matrix Alteration

Outcome Measures

Primary Outcomes (2)

• Evaluation of MMP-2, MMP-9 and NGAL levels in blood and aneurysms tissue

  MMP-2, MMP-9 and NGAL will be studied in both groups. Elisa Testing will be used to analyze the blood samples and Western blot analysis will be used for the tissue samples.

  1 year

• Evalutation of miRNAs levels in blood and aneurysms tissue

  Evaluation of miRNAs levels (in particular miR29b, miR-181a, miR-21, miR-150) will be studied in both groups. Stem-loop reverse-transcription PCR (RT-qPCR) method will be used for measuring individual microRNAs (miRNAs) in tissue and blood samples.

  1 year

Study Arms (2)

Group I

Patients affected by central and peripheral aneurismatic disease with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg). Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy). The investigation consist in: * taking a preoperative blood sample to evaluate the MMPs circulating levels * taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels

Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy)

Group II

Patients affected by central and peripheral aneurismatic disease with minimum statin daily dose. Patients will undergo Open Surgical Treatment of Aneurysm (Aneurysmectomy). The investigation consist in: * taking a preoperative blood sample to evaluate the MMPs circulating levels * taking an aneurismatic vassel wall istological sample with an intraoperative biopsy to evaluate the tissue MMPs and miRNAs levels

Procedure: Open Surgical Treatment of Aneurysm (Aneurysmectomy)

Interventions

Open Surgical Treatment of Aneurysm (Aneurysmectomy) PROCEDURE

Aneurysmectomy is a surgical procedure in which a localized, dilated, weakened section of an artery (aneurysm) is removed (resected). The artery is either replaced with a synthetic graft, as seen in an aneurysm in the chest (thoracic aneurysm), abdomen (abdominal aneurysm) or leg (femoral or popliteal aneurysm).

Group I; Group II

Eligibility Criteria

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

Study Population

Patients affected by central and peripheral aneurysmal disease are going to be recruited and then divided in two groups based on the dosage of the statin treatment: the first group with maximum statin daily dose ( Atorvastatin 80 mg, Simvastatin 40 mg, Rosuvastatin 40 mg), the second group with minimum statin daily dose. The latter will be defined as the control group.

You may qualify if:

• Patients under statins treatment with pleiotropic effect: Simvastatin, Rosuvastatin, Atorvastatin
• Patients underwent open aneurysm repair
• Age \>18
• signing informed consent

You may not qualify if:

• Patients with chronic diseases such as liver diseases
• Pazient whith malignant diseases
• Recreational drug intake and alcohol abuse
• Intake of statins other than those under study or in combination therapy

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

Related Publications (6)

• Serra R, Grande R, Montemurro R, Butrico L, Calio FG, Mastrangelo D, Scarcello E, Gallelli L, Buffone G, de Franciscis S. The role of matrix metalloproteinases and neutrophil gelatinase-associated lipocalin in central and peripheral arterial aneurysms. Surgery. 2015 Jan;157(1):155-62. doi: 10.1016/j.surg.2014.06.008. Epub 2014 Nov 1.

  PMID: 25444221 BACKGROUND

• de Franciscis S, Mastroroberto P, Gallelli L, Buffone G, Montemurro R, Serra R. Increased plasma levels of metalloproteinase-9 and neutrophil gelatinase-associated lipocalin in a rare case of multiple artery aneurysm. Ann Vasc Surg. 2013 Nov;27(8):1185.e5-7. doi: 10.1016/j.avsg.2013.01.011. Epub 2013 Aug 26.

  PMID: 23988549 BACKGROUND

• Serra R, Volpentesta G, Gallelli L, Grande R, Buffone G, Lavano A, de Franciscis S. Metalloproteinase-9 and neutrophil gelatinase-associated lipocalin plasma and tissue levels evaluation in middle cerebral artery aneurysms. Br J Neurosurg. 2014 May 5. doi: 10.3109/02688697.2014.913777. Online ahead of print.

  PMID: 24799278 BACKGROUND

• Piechota-Polanczyk A, Demyanets S, Mittlboeck M, Hofmann M, Domenig CM, Neumayer C, Wojta J, Klinger M, Nanobachvili J, Huk I. The Influence of Simvastatin on NGAL, Matrix Metalloproteinases and Their Tissue Inhibitors in Human Intraluminal Thrombus and Abdominal Aortic Aneurysm Tissue. Eur J Vasc Endovasc Surg. 2015 May;49(5):549-55. doi: 10.1016/j.ejvs.2015.02.011. Epub 2015 Mar 21.

  PMID: 25800096 BACKGROUND

• Maegdefessel L, Azuma J, Toh R, Merk DR, Deng A, Chin JT, Raaz U, Schoelmerich AM, Raiesdana A, Leeper NJ, McConnell MV, Dalman RL, Spin JM, Tsao PS. Inhibition of microRNA-29b reduces murine abdominal aortic aneurysm development. J Clin Invest. 2012 Feb;122(2):497-506. doi: 10.1172/JCI61598. Epub 2012 Jan 24.

  PMID: 22269326 BACKGROUND

• Adam M, Raaz U, Spin JM, Tsao PS. MicroRNAs in Abdominal Aortic Aneurysm. Curr Vasc Pharmacol. 2015;13(3):280-90. doi: 10.2174/15701611113119990015.

  PMID: 23713862 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stefano de Franciscis, M.D.

  University Magna Graecia of Catanzaro

  STUDY CHAIR

Central Study Contacts

Raffaele Serra, M.D.; Ph.D.

CONTACT

+39 09613647380; rserra@unicz.it

Luca Gallelli, M.D.; Ph.D.

CONTACT

+39 0961 3339245656; gallelli@unicz.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: February 15, 2017
• Primary Completion: February 26, 2018
• Study Completion: April 27, 2018
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)