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Long-term outcome of cervical artery dissection

IPSYS CeAD: study protocol, rationale, and baseline data of an Italian multicenter research collaboration

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Abstract

Long-term consequences of cervical artery dissection (CeAD), a major cause of ischemic stroke in young people, have been poorly investigated. The Italian Project on Stroke at Young Age – Cervical Artery Dissection (IPSYS CeAD) project is a multicenter, hospital-based, consecutively recruiting, observational, cohort study aimed to address clinically important questions about long-term outcome of CeAD patients, which are not covered by other large-scale registries. Patients with radiologically diagnosed CeAD were consecutively included in the registry. Baseline demographic and clinical variables, as well as information on risk factors, were systematically collected for each eligible patient. Follow-up evaluations were conducted between 3 and 6 months after the initial event (t1) and then annually (t2 at 1 year, t3 at 2 years , and so on), in order to assess outcome events (long-term recurrent CeAD, any fatal/nonfatal ischemic stroke, transient ischemic attack (TIA), or other arterial thrombotic event, and death from any cause). Between 2000 and 2019, data from 1530 patients (age at diagnosis, 47.2 ± 11.5 years; women, 660 [43.1%]) have been collected at 39 Italian neurological centers. Dissection involved a single vessel in 1308 (85.5%) cases and caused brain ischemia in 1303 (85.1%) (190 TIA/1113 ischemic stroke). Longitudinal data are available for 1414 (92.4%) patients (median follow-up time in patients who did not experience recurrent events, 36.0 months [25th to 75th percentile, 63.0]). The collaborative IPSYS CeAD effort will provide novel information on the long-term outcome of CeAD patients. This could allow for tailored treatment approaches based on patients’ individual characteristics.

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Funding

The Italian Project on Stroke in Young Adults (IPSYS) is supported by a grant from the Associazione per la Lotta alla Trombosi e alle Malattie Cardiovascolari (ALT).

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Correspondence to Alessandro Pezzini.

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Ethical approval

The study design was approved by the Ethical Committee of the Spedali Civili di Brescia, Italy (NP 74, 04/05/2010). Written, signed consent will be obtained from all participants or their legal representatives. Participants have the right to withdraw from the research process at any time throughout the study. All data are kept strictly confidential and patients are given a study ID number to maintain this confidentiality. Participation in this study does not interfere with usual patient care.

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The sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication.

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Alessandro Pezzini had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

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Bonacina, S., Grassi, M., Zedde, M. et al. Long-term outcome of cervical artery dissection. Neurol Sci 41, 3265–3272 (2020). https://doi.org/10.1007/s10072-020-04464-9

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