Lectine Pathway in Unstable Carotid Plaque

NCT ID: NCT03822195

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Artery Plaque Mannose-Binding Lectin Complement Pathway

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

asymptomatic

asymptomatic patients undergoing carotid endoarterectomy for stenosis \>70% (velocimetric criteria at echodoppler)

Carotid endoarterectomy

Intervention Type PROCEDURE

Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)

symptomatic

symptomatic (TIA, crescendo TIA, minor stroke) patients undergoing carotid endoarterectomy, independently from stenosis evaluated by echodoppler

Carotid endoarterectomy

Intervention Type PROCEDURE

Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carotid endoarterectomy

Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CEA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Angela M.R. Ferrante

Angela M.R. Ferrante MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Angela MR Ferrante, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A.Gemelli IRCCS Roma

References

Explore related publications, articles, or registry entries linked to this study.

Verhoeven B, Hellings WE, Moll FL, de Vries JP, de Kleijn DP, de Bruin P, Busser E, Schoneveld AH, Pasterkamp G. Carotid atherosclerotic plaques in patients with transient ischemic attacks and stroke have unstable characteristics compared with plaques in asymptomatic and amaurosis fugax patients. J Vasc Surg. 2005 Dec;42(6):1075-81. doi: 10.1016/j.jvs.2005.08.009.

Reference Type BACKGROUND
PMID: 16376194 (View on PubMed)

Longhi L, Orsini F, De Blasio D, Fumagalli S, Ortolano F, Locatelli M, Stocchetti N, De Simoni MG. Mannose-binding lectin is expressed after clinical and experimental traumatic brain injury and its deletion is protective. Crit Care Med. 2014 Aug;42(8):1910-8. doi: 10.1097/CCM.0000000000000399.

Reference Type BACKGROUND
PMID: 24810526 (View on PubMed)

Fust G, Munthe-Fog L, Illes Z, Szeplaki G, Molnar T, Pusch G, Hirschberg K, Szegedi R, Szeplaki Z, Prohaszka Z, Skjoedt MO, Garred P. Low ficolin-3 levels in early follow-up serum samples are associated with the severity and unfavorable outcome of acute ischemic stroke. J Neuroinflammation. 2011 Dec 29;8:185. doi: 10.1186/1742-2094-8-185.

Reference Type BACKGROUND
PMID: 22206485 (View on PubMed)

Osthoff M, Katan M, Fluri F, Schuetz P, Bingisser R, Kappos L, Steck AJ, Engelter ST, Mueller B, Christ-Crain M, Trendelenburg M. Mannose-binding lectin deficiency is associated with smaller infarction size and favorable outcome in ischemic stroke patients. PLoS One. 2011;6(6):e21338. doi: 10.1371/journal.pone.0021338. Epub 2011 Jun 21.

Reference Type BACKGROUND
PMID: 21712986 (View on PubMed)

Zangari R, Zanier ER, Torgano G, Bersano A, Beretta S, Beghi E, Casolla B, Checcarelli N, Lanfranconi S, Maino A, Mandelli C, Micieli G, Orzi F, Picetti E, Silvestrini M, Stocchetti N, Zecca B, Garred P, De Simoni MG; LEPAS group. Early ficolin-1 is a sensitive prognostic marker for functional outcome in ischemic stroke. J Neuroinflammation. 2016 Jan 20;13:16. doi: 10.1186/s12974-016-0481-2.

Reference Type BACKGROUND
PMID: 26792363 (View on PubMed)

Pilely K, Fumagalli S, Rosbjerg A, Genster N, Skjoedt MO, Perego C, Ferrante AMR, De Simoni MG, Garred P. C-Reactive Protein Binds to Cholesterol Crystals and Co-Localizes with the Terminal Complement Complex in Human Atherosclerotic Plaques. Front Immunol. 2017 Aug 29;8:1040. doi: 10.3389/fimmu.2017.01040. eCollection 2017.

Reference Type BACKGROUND
PMID: 28900428 (View on PubMed)

Hellings WE, Pasterkamp G, Vollebregt A, Seldenrijk CA, De Vries JP, Velema E, De Kleijn DP, Moll FL. Intraobserver and interobserver variability and spatial differences in histologic examination of carotid endarterectomy specimens. J Vasc Surg. 2007 Dec;46(6):1147-54. doi: 10.1016/j.jvs.2007.08.018. Epub 2007 Oct 22.

Reference Type BACKGROUND
PMID: 17950565 (View on PubMed)

Fumagalli S, Perego C, Zangari R, De Blasio D, Oggioni M, De Nigris F, Snider F, Garred P, Ferrante AM, De Simoni MG. Lectin Pathway of Complement Activation Is Associated with Vulnerability of Atherosclerotic Plaques. Front Immunol. 2017 Mar 16;8:288. doi: 10.3389/fimmu.2017.00288. eCollection 2017.

Reference Type RESULT
PMID: 28360913 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2124

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Norwegian Carotid Plaque Study
NCT02759653 COMPLETED