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Trial record 38 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Lectine Pathway in Unstable Carotid Plaque

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ClinicalTrials.gov Identifier: NCT03822195
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Angela M.R. Ferrante, Policlinico Universitario Agostino Gemelli

Brief Summary:
The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features.

Condition or disease Intervention/treatment
Carotid Artery Plaque Mannose-Binding Lectin Complement Pathway Procedure: Carotid endoarterectomy

Detailed Description:
In addition to the known hemodynamic criteria, instable carotid plaques can be responsible for brain ischemia, therefore is paramount to identify preoperatively possible markers of plaque instability. The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features. Study population will include 40 patients with internal carotid artery stenosis >=70% (assessed by echocolordoppler), symptomatic or asymptomatic, surgically treated by endoarterectomy. Removed plaques will be evaluated by histologic exam and immunofluorescence for ficolins 1-2-3 and Mannose Binding Lectin (MBL). Plasma samples will be used for ELISA test of lectin pathway complement activation.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Lectine Pathway in Assessment of Unstable Carotid Plaque
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Group/Cohort Intervention/treatment
asymptomatic
asymptomatic patients undergoing carotid endoarterectomy for stenosis >70% (velocimetric criteria at echodoppler)
Procedure: Carotid endoarterectomy
Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)
Other Name: CEA

symptomatic
symptomatic (TIA, crescendo TIA, minor stroke) patients undergoing carotid endoarterectomy, independently from stenosis evaluated by echodoppler
Procedure: Carotid endoarterectomy
Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)
Other Name: CEA




Primary Outcome Measures :
  1. lectine pathway of complement activation in carotid plaques [ Time Frame: preoperative ]
    assessment of association between plasmatic levels of complement activators and plaque instability (histologic index). Protein plasma levels will be assessed as optical density. Plaque instability will be quantified by a vulnerability score that combines four different histological parameters according to their quartile distribution (Fumagalli et al., Frontiers Immunology 2017). Their association will be analyzed as odds ratio (95%-CI) by a Fisher test.


Secondary Outcome Measures :
  1. focal neurologic symptoms and plasmatic levels of complement activators [ Time Frame: preoperative, postoperative day 3, 3 months after surgery ]
    Correlation of onset of focal neurologic symptoms (TIA, any stroke) due to carotid stenosis and peripheral plasma levels of complement activators. Neurological exam + CT or MNR will be used as clinical measurement tool

  2. focal neurologic symptoms and histologic index of plaque instability [ Time Frame: through study completion (average 1 year) ]
    correlation of onset of focal neurologic symptoms (TIA, any stroke) due to carotid stenosis and histologic index for plaque instability. Protein plasma levels will be assessed as optical density. Plaque instability will be quantified by a vulnerability score that combines four different histological parameters according to their quartile distribution (Fumagalli et al., Frontiers Immunology 2017).


Biospecimen Retention:   Samples With DNA
Atherosclerotic plaque surgically removed from the carotid bifurcation Peripheral blood sample


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will include 40 patients with symptomatic or asymptomatic internal carotid artery stenosis >=70% (measured by echocolordoppler) treated by elective or urgent endoarterectomy.
Criteria

Inclusion Criteria:

  • patients undergone elective or urgent carotid endoarterectomy (CEA) for internal carotid stenosis >70% (assessed by velocimetric criteria) with or without neurologic symptoms

Exclusion Criteria:

  • recent (<20 days) major/minor stroke with positive CT scan
  • absolute contraindications to surgery (cardiac, respiratory, anesthesiologic risk)

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): NCT03822195


Contacts
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Contact: Angela MR Ferrante, MD +39 0630156126 angelamaria.ferrante@unicatt.it

Sponsors and Collaborators
Policlinico Universitario Agostino Gemelli
Investigators
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Principal Investigator: Angela MR Ferrante, MD Fondazione Policlinico Universitario A.Gemelli IRCCS Roma

Publications of Results:
Other Publications:

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Responsible Party: Angela M.R. Ferrante, Angela M.R. Ferrante MD PhD, Policlinico Universitario Agostino Gemelli
ClinicalTrials.gov Identifier: NCT03822195     History of Changes
Other Study ID Numbers: 2124
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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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 Angela M.R. Ferrante, Policlinico Universitario Agostino Gemelli:
carotid artery atherosclerosis
alternative complement pathway

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases