Hemodynamics and Autonomic and Cognitive Performance After Carotid Revascularization Procedures

NCT03493971 | Completed DMC

• 2 other identifiers: 62/int/2017PE-2013-02355484
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases

Keywords

carotid endarterectomy; carotid stenting; autonomic function; computational fluid dynamic; cognitive function

Outcome Measures

Primary Outcomes (1)

• R-R interval (sec) and Systolic Arterial Pressure (SAP) (mmHg) in rest and tilt position for baroreceptor function

  Comparison pre- and post-CAS, Comparison pre- and post-CEA

  20 months

Secondary Outcomes (12)

• Cognitive P300 latency (ms)

  20 months

• Mean and maximum flow velocity magnitude (cm/sec) in common carotid artery (CCA) and internal carotid artery (ICA) along the cardiac cycle

  20 months

• Systolic wall shear stress (dyn/cm2)

  20 months

• Time-averaged wall shear stress (TAWSS) (dyn/cm2)

  20 months

• Oscillatory index (OSI) (%)

  20 months

Study Arms (2)

Carotid artery stenting (CAS)

ACTIVE COMPARATOR

Carotid revascularization performed using CAS

Procedure: Carotid revascularization performed using CAS

Carotid endarterectomy (CEA)

ACTIVE COMPARATOR

Carotid revascularization performed using CEA

Procedure: Carotid revascularization performed using CEA

Interventions

Carotid revascularization performed using CAS PROCEDURE

Carotid artery stenting (CAS) is an endovascular stent procedure used to treat narrowing of the carotid artery and decrease the risk of stroke

Carotid artery stenting (CAS)

Carotid revascularization performed using CEA PROCEDURE

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

Carotid endarterectomy (CEA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Donato: lead
• Emory University: collaborator
• University of Pavia: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (17)

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  PMID: 23184283 BACKGROUND

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  PMID: 9587331 BACKGROUND

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  PMID: 22922507 BACKGROUND

• Davies PF. Overview: temporal and spatial relationships in shear stress-mediated endothelial signalling. J Vasc Res. 1997 May-Jun;34(3):208-11. doi: 10.1159/000159224. No abstract available.

  PMID: 9226302 BACKGROUND

• Hathcock JJ. Flow effects on coagulation and thrombosis. Arterioscler Thromb Vasc Biol. 2006 Aug;26(8):1729-37. doi: 10.1161/01.ATV.0000229658.76797.30. Epub 2006 Jun 1.

  PMID: 16741150 BACKGROUND

• Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

  PMID: 2874900 BACKGROUND

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  PMID: 21067964 BACKGROUND

• Conti M, Van Loo D, Auricchio F, De Beule M, De Santis G, Verhegghe B, Pirrelli S, Odero A. Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations. J Endovasc Ther. 2011 Jun;18(3):397-406. doi: 10.1583/10-3338.1.

  PMID: 21679082 BACKGROUND

• Auricchio F, Conti M, Ferrara A, Morganti S, Reali A. Patient-specific finite element analysis of carotid artery stenting: a focus on vessel modeling. Int J Numer Method Biomed Eng. 2013 Jun;29(6):645-64. doi: 10.1002/cnm.2511. Epub 2012 Sep 29.

  PMID: 23729192 BACKGROUND

• Auricchio F, Conti M, Ferraro M, Reali A. Evaluation of carotid stent scaffolding through patient-specific finite element analysis. Int J Numer Method Biomed Eng. 2012 Oct;28(10):1043-55. doi: 10.1002/cnm.2509. Epub 2012 Aug 25.

  PMID: 23027634 BACKGROUND

• De Santis G, Conti M, Trachet B, De Schryver T, De Beule M, Degroote J, Vierendeels J, Auricchio F, Segers P, Verdonck P, Verhegghe B. Haemodynamic impact of stent-vessel (mal)apposition following carotid artery stenting: mind the gaps! Comput Methods Biomech Biomed Engin. 2013;16(6):648-59. doi: 10.1080/10255842.2011.629997. Epub 2011 Dec 8.

  PMID: 22149183 BACKGROUND

• De Santis G, Trachet B, Conti M, De Beule M, Morbiducci U, Mortier P, Segers P, Verdonck P, Verhegghe B. A computational study of the hemodynamic impact of open- versus closed-cell stent design in carotid artery stenting. Artif Organs. 2013 Jul;37(7):E96-106. doi: 10.1111/aor.12046. Epub 2013 Apr 12.

  PMID: 23578331 BACKGROUND

• Blanco PJ, Trenhago PR, Fernandes LG, Feijoo RA. On the integration of the baroreflex control mechanism in a heterogeneous model of the cardiovascular system. Int J Numer Method Biomed Eng. 2012 Apr;28(4):412-33. doi: 10.1002/cnm.1474. Epub 2011 Nov 2.

  PMID: 25365656 BACKGROUND

• Towfighi A, Saver JL. Stroke declines from third to fourth leading cause of death in the United States: historical perspective and challenges ahead. Stroke. 2011 Aug;42(8):2351-5. doi: 10.1161/STROKEAHA.111.621904. Epub 2011 Jul 21.

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• Bunch CT, Kresowik TF. Can randomized trial outcomes for carotid endarterectomy be achieved in community-wide practice? Semin Vasc Surg. 2004 Sep;17(3):209-13. doi: 10.1016/s0895-7967(04)00043-2.

  PMID: 15449242 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: April 11, 2018
• Study Start: March 21, 2018
• Primary Completion: April 20, 2022
• Study Completion: November 29, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)