Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting

Completed

Phase N/A Results N/A

Trial Description

New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery stenting (CAS). The aim was to assess correlation between selected laboratory markers and occurrence of new brain infarctions after CAS.

Detailed Description

Methods: All consecutive patients 1) with internal carotid artery stenosis >70%, 2) indicated to CAS, 3) with signed informed consent were enrolled to the prospective study during 16 months. All patients used dual antiplatelet therapy (acetylsalicylic acid [ASA] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS. Neurological examination and brain magnetic resonance imaging (MRI) were performed before and 24 hours after CAS in all patients. Venous blood samples were collected within 24 hours before CAS in all patients: hematology + reticulocytes, coagulation markers (PT, APTT, INR, Fbg, Clauss), vWF antigen, PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and clopidogrel resistance test). Blood samples for the assessment of anti Xa activity were collected during CAS. T-test was used for statistical evaluation.

Conditions

Interventions

  • Carotid stenting Device
    Intervention Desc: Procedures will be carried out via the femoral approach following a Seldinger technique. All patients will be on long-term aspirin (100 mg/day) and a 525-mg loading dose of clopidogrel. A dose of 10 000 units unfractionated heparin will be administered at the beginning of the intervention. A cerebral protection device (FilterWire EZ™; Boston Scientific, Natick, Massachusetts, USA) will be use in all patients if possible. The type of covered stent and other specific intervention strategies will be left to the discretion of the interventional radiologists. After predilatation of the stenosis (if needed), an appropriate stent for each stenosis will be implanted and then dilated using a balloon catheter.
    ARM 1: Kind: Experimental
    Label: Stenting
    Description: Carotid stenting

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

patients with internal carotid artery stenosis >70%, indicated to carotid stenting

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with change of level of selected laboratory markers as a measure of potential embolic complication of carotid stenting blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure Yes
Primary Number of participants with correlation of changed level of selected laboratory markers and occurence of new brain ischemic lesion as a measure of safety of carotid stenting procedure blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure Yes

Biospecimen Retention:Samples Without DNA - Blood samples collecting: hematology + reticulocytes, coagulation markers (PT, APTT, INR, Fbg, Clauss), vWF antigen, PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and clopidogrel resistance test) anti Xa activity

Sponsors