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

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.

Study Overview

• Status: Completed
• Conditions: Brain Ischemia; Carotid Stenosis; Laboratory Problem
• Intervention / Treatment: Procedure: Carotid stenting

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Czech Republic
  • Ostrava, Czech Republic, 70800
    • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Stenting; Carotid stenting

Procedure: Carotid stenting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with change of level of selected laboratory markers as a measure of potential embolic complication of carotid stenting	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	blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure
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	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	blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Martin Kuliha, MD, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: carotid stenting; ischemic stroke; MRI diffusion weighted imaging; Laboratory marker
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Brain Ischemia; Ischemia; Carotid Stenosis
• Other Study ID Numbers: UHOG-2/2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No