Clinical trial NCT02310191: Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting
Official title: Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Brain Ischemia
Laboratory Problem
Keywords: ischemic stroke
carotid stenting
MRI diffusion weighted imaging
Laboratory marker
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with internal carotid artery stenosis \>70%, indicated to carotid stenting

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with change of level of selected laboratory markers as a measure of potential embolic complication of carotid stenting
timeFrame: blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure
measure: 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
timeFrame: blood samples were collected within 24 hours before CAS and anti Xa activity blood samples are collected during CAS procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Martin Kuliha, MD
role: PRINCIPAL_INVESTIGATOR
References: