Detecting the vulnerable carotid plaque: the Carotid Artery Multimodality imaging Prognostic study design.


Journal

Journal of cardiovascular medicine (Hagerstown, Md.)
ISSN: 1558-2035
Titre abrégé: J Cardiovasc Med (Hagerstown)
Pays: United States
ID NLM: 101259752

Informations de publication

Date de publication:
01 07 2022
Historique:
aheadofprint: 23 06 2022
entrez: 28 6 2022
pubmed: 29 6 2022
medline: 1 7 2022
Statut: ppublish

Résumé

Carotid artery disease is highly prevalent and a main cause of ischemic stroke and vascular dementia. There is a paucity of information on predictors of serious vascular events. Besides percentage diameter stenosis, international guidelines also recommend the evaluation of qualitative characteristics of carotid artery disease as a guide to treatment, but with no agreement on which qualitative features to assess. This inadequate knowledge leads to a poor ability to identify patients at risk, dispersion of medical resources, and unproven use of expensive and resource-consuming techniques, such as magnetic resonance imaging, positron emission tomography, and computed tomography. The Carotid Artery Multimodality imaging Prognostic (CAMP) study will: prospectively determine the best predictors of silent and overt ischemic stroke and vascular dementia in patients with asymptomatic subcritical carotid artery disease by identifying the noninvasive diagnostic features of the 'vulnerable carotid plaque'; assess whether 'smart' use of low-cost diagnostic methods such as ultrasound-based evaluations may yield at least the same level of prospective information as more expensive techniques. We will compare the prognostic/predictive value of all proposed techniques with regard to silent or clinically manifest ischemic stroke and vascular dementia. The study will include ≥300 patients with asymptomatic, unilateral, intermediate degree (40-60% diameter) common or internal carotid artery stenosis detected at carotid ultrasound, with a 2-year follow-up. The study design has been registered on Clinicaltrial.gov on December 17, 2020 (ID number NCT04679727).

Sections du résumé

BACKGROUND
Carotid artery disease is highly prevalent and a main cause of ischemic stroke and vascular dementia. There is a paucity of information on predictors of serious vascular events. Besides percentage diameter stenosis, international guidelines also recommend the evaluation of qualitative characteristics of carotid artery disease as a guide to treatment, but with no agreement on which qualitative features to assess. This inadequate knowledge leads to a poor ability to identify patients at risk, dispersion of medical resources, and unproven use of expensive and resource-consuming techniques, such as magnetic resonance imaging, positron emission tomography, and computed tomography.
OBJECTIVES
The Carotid Artery Multimodality imaging Prognostic (CAMP) study will: prospectively determine the best predictors of silent and overt ischemic stroke and vascular dementia in patients with asymptomatic subcritical carotid artery disease by identifying the noninvasive diagnostic features of the 'vulnerable carotid plaque'; assess whether 'smart' use of low-cost diagnostic methods such as ultrasound-based evaluations may yield at least the same level of prospective information as more expensive techniques.
STUDY DESIGN
We will compare the prognostic/predictive value of all proposed techniques with regard to silent or clinically manifest ischemic stroke and vascular dementia. The study will include ≥300 patients with asymptomatic, unilateral, intermediate degree (40-60% diameter) common or internal carotid artery stenosis detected at carotid ultrasound, with a 2-year follow-up. The study design has been registered on Clinicaltrial.gov on December 17, 2020 (ID number NCT04679727).

Identifiants

pubmed: 35763768
doi: 10.2459/JCM.0000000000001314
pii: 01244665-202207000-00008
doi:

Banques de données

ClinicalTrials.gov
['NCT04679727']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

466-473

Informations de copyright

Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.

Références

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Auteurs

Luna Gargani (L)

Institute of Clinical Physiology, National Research Council.

Matteo Baldini (M)

Medical School, University of Pisa, Pisa, Italy.

Raffaella Berchiolli (R)

Vascular Surgery Unit, Cardio Thoracic and Vascular Department, University of Pisa.

Ida Rebecca Bort (IR)

Medical School, University of Pisa, Pisa, Italy.

Giancarlo Casolo (G)

Cardiology Department, Versilia Hospital, Lido di Camaiore.

Dante Chiappino (D)

Fondazione Toscana Gabriele Monasterio.

Mirco Cosottini (M)

Neuroradiology Unit, University of Pisa, Pisa, Italy.

Gennaro D'Angelo (G)

Institute of Clinical Physiology, National Research Council.

Mariella De Santis (M)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Paola Erba (P)

Department of Nuclear Medicine, University of Pisa, Pisa, Italy.
Medical Imaging Center, Department of Nuclear Medicine & Molecular Imaging, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Iacopo Fabiani (I)

Fondazione Toscana Gabriele Monasterio.

Plinio Fabiani (P)

Internal Medicine, S.M. Annunziata Hospital, Florence, Italy.

Ilaria Gabbriellini (I)

Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Gian Giacomo Galeotti (GG)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Irene Ghicopulos (I)

Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Isabel Goncalves (I)

Department of Clinical Sciences - Malmö University Hospital, University of Lund, Malmö, Sweden.

Simone Lapi (S)

BMS Multispecialistic Biobank-Biobank Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Gabriele Masini (G)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Carmela Morizzo (C)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Vinicio Napoli (V)

Diagnostic and Interventional Radiology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Jan Nilsson (J)

Department of Clinical Sciences - Malmö University Hospital, University of Lund, Malmö, Sweden.

Giovanni Orlandi (G)

Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Carlo Palombo (C)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

Francesco Pieraccini (F)

Internal Medicine, S.M. Annunziata Hospital, Florence, Italy.

Stefano Ricci (S)

Department of Information Engineering (DINFO), University of Florence, Florence, Italy.

Gabriele Siciliano (G)

Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Riemer H J A Slart (RHJA)

Medical Imaging Center, Department of Nuclear Medicine & Molecular Imaging, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Department of Biomedical Photonic Imaging, Faculty of Science and Technology, University of Twente, Enschede, The Netherlands.

Raffaele De Caterina (R)

Cardiology Unit, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.

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