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

Completed

• Conditions: Carotid Stenosis; Laboratory Problem; Brain Ischemia
• Interventions: Procedure: Carotid stenting

• Registration Number: NCT02310191
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-21
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-03
• Last Update Submitted: 2014-12-03
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

patients

1. With internal carotid artery stenosis >70%
2. Indicated to CAS
3. With signed informed consent. Able to use (acetylsalicylic acid [ASA] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS

Exclusion Criteria

• Contraindication for magnetic resonance imaging

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stenting	Carotid stenting	Carotid stenting

Primary Outcome Measures

Name	Time	Method
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	Laboratory markers:erytrocytes, reticulocyte index, reticulocytes, platelet count, immature platelet fraction, mean platelet volume, prothrombin time (PT), activated parcial tromboplastine time (APTT), international normalized ratio (INR), Fibrinogen (Fbg), Clauss fibrinogen,von Willebrand factor (vWF) antigen, plasminogen activator inhibitor-1 (PAI-1) activity, PAI-1 polymorphism 4G/5G, Multiplate aggregometry , anti Xa activity
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	Laboratory markers:erytrocytes, reticulocyte index, reticulocytes, platelet count, immature platelet fraction, mean platelet volume, prothrombin time (PT), activated parcial tromboplastine time (APTT), international normalized ratio (INR), Fibrinogen (Fbg), Clauss fibrinogen,von Willebrand factor (vWF) antigen, plasminogen activator inhibitor-1 (PAI-1) activity, PAI-1 polymorphism 4G/5G, Multiplate aggregometry , anti Xa activity

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic