Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis

NCT ID: NCT02124928

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-12-31

Brief Summary

The aim of this study is to investigate the association of sonographic and histological features of the plaque among each other and with biomarkers of cardiovascular risk. The predictive value of these factors concerning the long-term clinical outcome after carotid endarterectomy will also be assessed. This may help to improve the identification of patients with carotid artery stenosis who will benefit most from carotid endarterectomy. The investigators major hypothesis is that the morphology of carotid plaques is associated with objectifiable sonographic parameters, in particular with the greyscale median. Second, the investigators hypothesize that sonographic and histological plaque morphology are associated with certain biomarkers of cardiovascular risk. Identification of 'vulnerable plaques' on the basis of a peripheral blood draw and a sonographic investigation may enable the treating physician to focus resources on patients who will benefit most form therapeutic interventions for primary prevention of ischemic stroke.

Detailed Description

The indication for revascularization of carotid artery stenoses is typically based on the degree of stenosis and the presence of symptoms. Recent evidence suggests that the risk of embolization from an atherosclerotic plaque may be associated with plaque density as assessed sonographically by determination of the greyscale median. Also, an association of serum proteins vascular endothelial growth factor (VEGF), hypoxia inducible factor (HIF) and pigment epithelium-derived factor (PEDF), matrix metalloproteinases 2, 8 and 9 with unstable plaques has been reported.

The VUCAP study will include patients undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery disease. Sonographic and serological markers of plaque vulnerability will be compared with histological features of the plaque and clinical presentation (symptomatic vs. asymptomatic). Preoperatively, the greyscale median of the plaque is assessed. Histomorphological investigation of the carotid plaques will be performed. Serological investigations will include markers of inflammation, thrombo-modulatory factors, lipid fractions and other parameters that have been associated with unstable plaques.

The aim of the present study is to assess the ability of pigment epithelium-derived factor (PEDF), vascular endothelial growth factor (VEGF), hypoxia-induced factor 1 alpha (HIF 1-α), matrix metalloproteinases 2, 8 and 9 to differentiate between vulnerable and stable carotid artery plaques. Identification of 'vulnerable plaques' on the basis of a peripheral blood draw and a sonographic investigation may enable the treating physician to focus resources on patients who will benefit most form therapeutic interventions for primary prevention of ischemic stroke.

Conditions

Atherosclerosis; Carotid Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

carotid artery stenosis

Patients with symptomatic or asymptomatic carotid artery stenosis indicated for carotid endarterectomy, who provide written informed consent, will be included in this study. The investigators will compare patients ultrasonographic data, serum laboratory analyses and histomorphological preferances to look for biomarkers for the plaque instability.

Carotid endarterectomy

Intervention Type: PROCEDURE

Carotid endarterectomy is a surgery used to reduce the risk of stroke, by correcting stenosis in the carotid artery. Endarterectomy is the removal of material on the inside (end-) of an artery.An incision is made on the midline side of the Sternocleidomastoid muscle. The incision is between 5 and 10 cm in length. Then the patients get 5000 IU heparin by the anesthesia. The internal, common and external carotid arteries are carefully identified, controlled with vessel loops, and clamped. The lumen of the internal carotid artery is opened, and the atheromatous plaque removed. The artery is closed using suture. The procedure is performed under local anesthesia. Local anesthesia, opposite to general, allows for direct monitoring of neurological status by intra-operative verbal contact and testing of grip strength.

Interventions

Carotid endarterectomy

Carotid endarterectomy is a surgery used to reduce the risk of stroke, by correcting stenosis in the carotid artery. Endarterectomy is the removal of material on the inside (end-) of an artery.An incision is made on the midline side of the Sternocleidomastoid muscle. The incision is between 5 and 10 cm in length. Then the patients get 5000 IU heparin by the anesthesia. The internal, common and external carotid arteries are carefully identified, controlled with vessel loops, and clamped. The lumen of the internal carotid artery is opened, and the atheromatous plaque removed. The artery is closed using suture. The procedure is performed under local anesthesia. Local anesthesia, opposite to general, allows for direct monitoring of neurological status by intra-operative verbal contact and testing of grip strength.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• asymptomatic stenosis of internal carotid artery >70%
• symptomatic stenosis of internal carotid artery >60%
• planed surgical treatment of the stenosis

Exclusion Criteria

• pregnancy
• symptomatic coronary heart disease
• myocardial infarction or acute coronary syndrome in the past 3 months
• acute peripheral artery occlusion in the past 3 months
• immaturity
• existence of a guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilhelminenspital Vienna

OTHER

Sponsor Role: collaborator

Prim PD Dr Afshin Assadian

OTHER

Sponsor Role: lead

Responsible Party

Prim PD Dr Afshin Assadian

Prim PD Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Afshin Assadian, Prim PD Dr

Role: PRINCIPAL_INVESTIGATOR

Georg Hagmüller Institute for Vascular Research Wilheminenspital Vienna, Austria

Locations

Surgery Departement, Georg Hagmüller Institute for Vascular Research Wilheminenspital

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Afshin Assadian, Prim PD Dr

Role: CONTACT

afshin.assadian@wienkav.at

+43 1 49150 ext. 4101

Jelena Basic, Dr

Role: CONTACT

jelenazbasic@gmail.com

+43 1 49150 ext. 4101

Facility Contacts

Afshin Assadian, Prim PD Dr

Role: primary

afshin.assadian@wienkav.at

+43 1 49150 ext. 4101

Jelena Basic, Dr

Role: backup

jelenazbasic@gmail.com

+43 1 49150 ext. 4101

Other Identifiers

EK-11-208-VK

Identifier Type: OTHER

Identifier Source: secondary_id

VUCAP

Identifier Type: -

Identifier Source: org_study_id