Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310191
Other study ID # UHOG-2/2012
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT03631381 - Retrospective Study of Carotid Surgery in Dijon
Completed NCT05437991 - Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Completed NCT02336958 - Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration N/A
Completed NCT02630862 - Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization N/A
Completed NCT00536796 - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets N/A
Recruiting NCT05566301 - Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)
Completed NCT03303534 - Short-Term Endogenous Hydrogen Sulfide Upregulation N/A
Completed NCT01480206 - Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
Recruiting NCT05250349 - TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Recruiting NCT05845710 - Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) N/A
Recruiting NCT01732523 - Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS
Completed NCT01315288 - A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis N/A
Withdrawn NCT00401921 - A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy Phase 2
Recruiting NCT01273350 - A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin) N/A
Completed NCT03215550 - PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Completed NCT03215563 - PET-MRI Imaging in Patients With Acute Neurovascular Syndrome
Completed NCT04553549 - Safety and Feasibility of the Infinity Catheter for Radial Access
Completed NCT03596229 - Major Adverse Cardiac Events After Carotid Endarterectomy
Completed NCT04255316 - Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation N/A