The Carotid Artery Multi-modality Imaging Prognostic (CAMP) Study

NCT04679727 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-11-15

No results posted yet for this study

Summary

Carotid artery disease is a main cause of ischemic stroke and vascular dementia, and a highly prevalent disease. There is uncertainty about the optimal management of patients with serendipitously or systematically detected asymptomatic carotid artery disease, due to the paucity of information on the predictive features of serious vascular events. While percent diameter stenosis is currently the accepted standard to decide about local interventions (carotid artery stenting or endarterectomy), international guidelines also recommend the evaluation of qualitative features of carotid artery disease as a guide to treatment. There is, however, no agreement on which qualitative features are best predictors of events. Furthermore, a role for metabolic plaque profile, local mechanical and hemorheologic factors in triggering microembolization and silent ischemic events has been proposed from experimental studies. This inadequate knowledge leads to a poor ability to identify patients at higher risk and to an unwarranted dispersion of medical resources, lack of standardization in diagnostic methods, and the use of expensive and resource-consuming techniques.

Against this background, the investigators aim at:

1. Prospectively identifying the best predictors of (silent and overt) ischemic stroke and vascular dementia in patients with asymptomatic subcritical carotid artery disease, by identifying the non-invasive diagnostic features of the "vulnerable carotid plaque" as a possible guide for optimal - local and systemic - treatment.
2. Transferring new ultrasound techniques possibly improving risk prediction to the clinical field
3. Assess whether "smart", low-cost diagnostic methods, such as ultrasound-based evaluations integrating established and advanced techniques, may yield at least the same level of prospective information as more expensive and less cost-effective techniques.

Conditions

  • Carotid Artery Diseases
  • Carotid Artery Plaque
  • Carotid Atherosclerosis

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER
  • Azienda USL Toscana Nord Ovest

    collaborator OTHER
  • Fondazione Toscana Gabriele Monasterio

    collaborator OTHER
  • Lund University Hospital

    collaborator OTHER
  • University Medical Center Groningen

    collaborator OTHER
  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • Raffaele De Caterina, MD · Azienda Ospedaliero, Universitaria Pisana

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2023-07-19
Completion
2024-07-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679727 on ClinicalTrials.gov