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Trial record 9 of 10 for:    "Carotid Stenosis" | "Clopidogrel"

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

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ClinicalTrials.gov Identifier: NCT02310191
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Carotid Stenosis Brain Ischemia Laboratory Problem 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.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting
Study Start Date : July 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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.




Primary Outcome Measures :
  1. Number of participants with change of level of selected laboratory markers as a measure of potential embolic complication of carotid stenting [ Time Frame: 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

  2. 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 [ Time Frame: 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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with internal carotid artery stenosis >70%, indicated to carotid stenting
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310191


Locations
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Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 70800
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Martin Kuliha, MD University Hospital Ostrava

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02310191     History of Changes
Other Study ID Numbers: UHOG-2/2012
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University Hospital Ostrava:
ischemic stroke
carotid stenting
MRI diffusion weighted imaging
Laboratory marker

Additional relevant MeSH terms:
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Carotid Stenosis
Brain Ischemia
Ischemia
Pathologic Processes
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases