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

NCT04679727 | Unknown

• 1 other identifier: CAMP study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Transferring new ultrasound techniques possibly improving risk prediction to the clinical field
3. 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

Outcome Measures

Primary Outcomes (2)

• Number of participants developing TIA/stroke and/or subclinical ischemic lesions

  The incidence of TIA/stroke and, mainly, the development of subclinical ischemic lesions, as demonstrated by the comparative evaluation of two brain MRI, one at baseline - at the time of acquisition of the carotid plaque characteristics by the multiple techniques here used - and at a 2-year follow-up.

  2 years

• Number of participants developing neurocognitive decline

  Neurocognitive decline, as assessed by comparative neurocognitive testing, at baseline, and at the 2-year follow-up

  2 years

Secondary Outcomes (1)

• The cost of the least expensive effective pathway

  3 years

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aging 45 to 85 years, with asymptomatic monolateral carotid artery lesions between 40 and 60% stenosis at carotid artery ultrasound.

You may qualify if:

• Asymptomatic carotid artery lesions between 40 and 60%, at carotid artery ultrasound, for which lesions an interventional strategy - beside optimal medical therapy - is not clearly defined.
• Patients with asymptomatic carotid artery stenosis higher than 60% will be enrolled when revascularization by either carotid endarterectomy (CEA) or stenting will be considered not indicated or not feasible
• Both genders (with capping implemented in order to ensure a 50±5% balance of males to females),

You may not qualify if:

• Severe comorbidities a priori precluding the 2-year follow-up (cachexia; end-stage cancer; severe renal/respiratory insufficiency; advanced (class IV) heart failure; atrial fibrillation and other significant arrhythmias).
• Severe allergic diathesis; contraindications to contrast agents for angio-TC or MRI; claustrophobia; presence of prostheses/implanted electronic devices not suitable for MRI; lack of consent for any reason.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead
• University of Florence: collaborator
• Azienda USL Toscana Nord Ovest: collaborator
• Fondazione Toscana Gabriele Monasterio: collaborator
• Lund University Hospital: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56124, Italy

RECRUITING

Related Publications (9)

• Fabiani I, Palombo C, Caramella D, Nilsson J, De Caterina R. Imaging of the vulnerable carotid plaque: Role of imaging techniques and a research agenda. Neurology. 2020 May 26;94(21):922-932. doi: 10.1212/WNL.0000000000009480. Epub 2020 May 11.

  PMID: 32393647 BACKGROUND

• Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

  PMID: 23652265 BACKGROUND

• Feigin VL, Norrving B, Mensah GA. Global Burden of Stroke. Circ Res. 2017 Feb 3;120(3):439-448. doi: 10.1161/CIRCRESAHA.116.308413.

  PMID: 28154096 BACKGROUND

• Barrett KM, Brott TG. Stroke Caused by Extracranial Disease. Circ Res. 2017 Feb 3;120(3):496-501. doi: 10.1161/CIRCRESAHA.117.310138.

  PMID: 28154099 BACKGROUND

• Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.

  PMID: 7678184 BACKGROUND

• Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005 Nov;58(5):688-97. doi: 10.1002/ana.20617.

  PMID: 16240340 BACKGROUND

• Lim JS, Kwon HM. Risk of "silent stroke" in patients older than 60 years: risk assessment and clinical perspectives. Clin Interv Aging. 2010 Sep 7;5:239-51. doi: 10.2147/cia.s7382.

  PMID: 20852671 BACKGROUND

• Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889.

  PMID: 26888534 BACKGROUND

• Gargani L, Baldini M, Berchiolli R, Bort IR, Casolo G, Chiappino D, Cosottini M, D'Angelo G, De Santis M, Erba P, Fabiani I, Fabiani P, Gabbriellini I, Galeotti GG, Ghicopulos I, Goncalves I, Lapi S, Masini G, Morizzo C, Napoli V, Nilsson J, Orlandi G, Palombo C, Pieraccini F, Ricci S, Siciliano G, Slart RHJA, De Caterina R. Detecting the vulnerable carotid plaque: the Carotid Artery Multimodality imaging Prognostic study design. J Cardiovasc Med (Hagerstown). 2022 Jul 1;23(7):466-473. doi: 10.2459/JCM.0000000000001314. Epub 2022 Jun 23.

  PMID: 35763768 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Raffaele De Caterina, MD

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele De Caterina, MD

CONTACT

+39050996975; raffaele.decaterina@unipi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: October 7, 2020
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

IT (1)