Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03840265
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
National Research, Development and Innovation Office
Information provided by (Responsible Party):
Prof. Dr. Sótonyi Péter, Semmelweis University Heart and Vascular Center

Brief Summary:

As of today, no suitable multiparametric predictive method is available to properly estimate stroke risk in patients with carotid artery stenosis. Carotid artery stenosis is one of the proven risk factors of stroke incidence, but the indication of its intervention is merely the grade of stenosis itself. The current international guidelines suggest intervention for asymptomatic patients only with potentially high risk plaques but pharmacological treatment is advised to low risk patients. Unfortunately there is no proven and widely accepted system to distinguish these two categories of patients with carotid artery stenosis.

In this project the following parameters will be assessed both in asymptomatic and symptomatic patients: 1, preoperative stroke risk prediction based on comparative analysis of CT angiography (CTA) results of plaque morphology and ultrasound (US) based plaque elastography analysis, 2) intracranial bloodflow will be measured by transcranial Doppler sonography(TCD), 3) presence recent of silent brain ischemia on diffusion weighted imaging (DWI) MR, 4) retinal perfusion measurement by optical coherence tomography angiography (OCT). The investigators aim to establish a clinically meaningful and more accurate (than stenosis grade) stroke risk prediction algorithm for asymptomatic carotid stenosis patients based on these parameters.


Condition or disease Intervention/treatment Phase
Carotid Stenosis Carotid Artery Plaque Cerebrovascular Embolism and Thrombosis Procedure: carotid endarterectomy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders Based on Morphological and Hemodynamical Features
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Carotid endarterectomy
All patients in this study will undergo carotid endarterectomy procedure
Procedure: carotid endarterectomy
In this project the following parameters will be assessed both in asymptomatic and symptomatic patients underwent carotid endarterectomy: 1) hemodynamic modeling of effect of the supraaortic arteries anatomic variations and pathologies 2, preoperative stroke risk prediction based on comparative analysis of CTA results of plaque morphology and ultrasound-based plaque elastography analysis, 3) cerebral flow measurement by transcranial Doppler sonography(TCD), 4) presence recent of silent brain ischemia on DWI-MRI, 5) OCT angiography could be a useful non-invasive method for evaluation of the outcome of carotid interventions
Other Names:
  • Cranial MR
  • Transcranial Doppler Ultrasound
  • Optical coherence tomography angiography
  • Carotid CT angiography




Primary Outcome Measures :
  1. Neurological event [ Time Frame: Periprocedural (0-78h after the carotid endarterectomy) ]
    Neurological event can be definitive stroke or transient ischemic attack (TIA). Any neurological events, which can occur in the postoperative 0-78 hours is defined as neurological event. The patients with neurological event will be scored in Rankin scale and will undergo cranial CT and CTA to verify the acute brain ischemia. Patients without any neurological event, who has silent new DWI lesions in postoperative cranial MR, count to be asymptomatic and do not fulfill the positive outcome criteria. Patients with peripheral nerve damage (common complication of cervical operations) count to be asymptomatic and do not fulfill the positive outcome criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent,
  • significant carotid artery stenosis

Exclusion Criteria:

  • Age under 50 years
  • Neurological event 15 days before operation
  • Chronic kidney disease
  • Pacemaker or ICD implantation
  • Atrial fibrillation

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): NCT03840265


Contacts
Layout table for location contacts
Contact: Zsuzsanna Mihály, MD +36-20-666-3673 zsuzsannamihaly@gmail.com
Contact: Andrea Mészáros +36-20-666-3227 meszaros.andrea@med.semmelweis-univ.hu

Locations
Layout table for location information
Hungary
Semmelweis University Heart and Vascular Centre Recruiting
Budapest, Budapest XII, Hungary, 1122
Contact: Zsuzsanna Mihály    +36-20-666-3673    zsuzsannamihaly@gmail.com   
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
National Research, Development and Innovation Office
Investigators
Layout table for investigator information
Study Director: Péter Sótonyi, MD PhD Semmelweis University Heart and Vascular Centre

Layout table for additonal information
Responsible Party: Prof. Dr. Sótonyi Péter, MD, PhD, Head of Vascular Surgery Department of Semmelweis University, Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03840265     History of Changes
Other Study ID Numbers: SemmelweisUHVC
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Stenosis
Thrombosis
Embolism
Embolism and Thrombosis
Carotid Artery Diseases
Intracranial Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Thromboembolism