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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310191
• Other study ID #: UHOG-2/2012
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: December 3, 2014
• Start date: July 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Ischemia
• Carotid Stenosis
• Laboratory Problem

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	University Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	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	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	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	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	Yes