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Hemodynamics and Autonomic and Cognitive Performance After Carotid Revascularization Procedures (BAROX)

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ClinicalTrials.gov Identifier: NCT03493971
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Emory University
University of Pavia
Information provided by (Responsible Party):
Massimiliano M. Marrocco-Trischitta, Ospedale San Donato

Brief Summary:
Carotid revascularization procedures are performed for more than 87% of cases in patients with asymptomatic internal carotid stenosis (ICS), who are assumed to have a life expectancy of at least 5 years. Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints in patients with uneventful perioperative course. CEA and CAS, as a consequence of either surgical trauma or mechanical stimuli related to the compliance mismatch between the stented segment and the native artery, may perturb carotid baroreceptors function causing an impairment of cardiovascular autonomic control. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications. Finally, long-term and sustained cognitive benefits after CAS as compared to CEA are yet to be demonstrated.

Condition or disease Intervention/treatment Phase
Carotid Artery Diseases Procedure: Carotid revascularization performed using CAS Procedure: Carotid revascularization performed using CEA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Carotid Endarterectomy and Stenting on Hemodynamics, Fluid-structure Interaction, Autonomic Modulation, and Cognitive Brain Function
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Carotid artery stenting (CAS)
Carotid revascularization performed using CAS
Procedure: Carotid revascularization performed using CAS
Carotid artery stenting (CAS) is an endovascular stent procedure used to treat narrowing of the carotid artery and decrease the risk of stroke

Active Comparator: Carotid endarterectomy (CEA)
Carotid revascularization performed using CEA
Procedure: Carotid revascularization performed using CEA
Carotid endarterectomy (CEA) is a surgical procedure used to correct stenosis in the common carotid artery or internal carotid artery and reduce the risk of stroke




Primary Outcome Measures :
  1. R-R interval (sec) and Systolic Arterial Pressure (SAP) (mmHg) in rest and tilt position for baroreceptor function [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA


Secondary Outcome Measures :
  1. Cognitive P300 latency (ms) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  2. Mean and maximum flow velocity magnitude (cm/sec) in common carotid artery (CCA) and internal carotid artery (ICA) along the cardiac cycle [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  3. Systolic wall shear stress (dyn/cm2) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  4. Time-averaged wall shear stress (TAWSS) (dyn/cm2) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  5. Oscillatory index (OSI) (%) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  6. Flow helicity (-) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  7. CCA/ICA Flow split (%) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  8. Common carotid artery (CCA) - internal carotid artery (ICA) mean and maximum pressure drop (mmHg) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  9. Carotid wall von Mises stress (dyn/cm2) at the systolic peak [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  10. Carotid wall maximum principal stress (dyn/cm2) at the systolic peak and corresponding directions (-) Maximum, mean, and min principal strain (-) and corresponding directions (-) [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  11. Carotid augmentation index (%) of pressure wave [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA

  12. Effective reflecting distance (mm) of pressure wave [ Time Frame: 20 months ]
    Comparison pre- and post-CAS, Comparison pre- and post-CEA



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed
  • Patients with >=70% symptomatic or >=80% asymptomatic internal carotid stenosis

Exclusion Criteria:

  • Incapability to give informed consent
  • Previous disabling stroke
  • Contralateral carotid occlusion or >70% stenosis
  • Systemic disease judged non compatible with the procedures or randomization
  • Suspected or manifested pregnancy
  • General contraindications to MRI or CT studies

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): NCT03493971


Locations
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Italy
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Massimiliano M Marrocco Trischitta, MD    (+39) 025277 ext 4344    Massimiliano.MarroccoTrischitta@grupposandonato.it   
Contact: Daniela Mazzaccaro, MD    (+39) 025277 ext 4341    Daniela.Mazzaccaro@grupposandonato.it   
Sponsors and Collaborators
Ospedale San Donato
Emory University
University of Pavia

Publications:

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Responsible Party: Massimiliano M. Marrocco-Trischitta, MD, PhD, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT03493971     History of Changes
Other Study ID Numbers: 62/int/2017
PE-2013-02355484 ( Other Grant/Funding Number: Ministero della Salute, Italia )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimiliano M. Marrocco-Trischitta, Ospedale San Donato:
carotid endarterectomy
carotid stenting
autonomic function
computational fluid dynamic
cognitive function
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases