NCT02310191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

November 21, 2014

Last Update Submit

December 3, 2014

Conditions

Carotid StenosisBrain IschemiaLaboratory Problem

Keywords

ischemic strokecarotid stentingMRI diffusion weighted imagingLaboratory marker

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Stenting

Carotid stenting

Procedure: Carotid stenting

Interventions

Carotid stentingPROCEDURE

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.

Stenting

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients
  • With internal carotid artery stenosis \>70%
  • Indicated to CAS
  • With signed informed consent. Able to use (acetylsalicylic acid \[ASA\] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS

You may not qualify if:

  • Contraindication for magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, 70800, Czechia

Location

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

MeSH Terms

Conditions

Carotid StenosisBrain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Martin Kuliha, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 8, 2014

Study Start

July 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

CZ(1)