DiagnosE Using the Central veIn SIgn
Fjalë kyçe
Abstrakt
Përshkrim
The North American Imaging in MS Cooperative has reviewed the utility of the central vein sign (CVS) in the diagnosis of MS in 2015. They concluded that "To formally establish the clinical value of the CVS for the differential diagnosis at disease onset, a large, prospective, multicentre study including patients at first presentation of possible MS is necessary". The paper outlining the 2017 McDonald diagnostic criteria for MS specifically mentions the promise of the CVS but suggests that it "requires detailed investigation to determine whether it is useful and practical". The rationale of this study is to provide an overwhelming case for a straightforward and rapid clinical adoption of our MRI test, which will change our ability to confirm or refute the diagnosis of MS.
Radiologists and neurologists can also readily interpret our proposed CVS using a simple 'rule of six' that was described in a previous study. This involves the detection of any six lesions with a central vein present. This rule has the potential to be easily implemented in clinical practice if it has superior diagnostic sensitivity, when compared to lumbar puncture results.
If the CVS can be shown to have superior diagnostic sensitivity at first presentation of MS, when compared to performing a lumbar puncture, then lumbar punctures can be avoided in many patients. These patients will benefit in several ways. The patients will avoid a procedure that is often painful or unpleasant. Those who currently refuse to have lumbar puncture will benefit from expedited diagnosis, limiting their anxiety and uncertainty. A secure diagnosis could lead to more rapid treatment decisions and a better long-term prognosis. In addition, fewer workdays will be lost attending hospital for investigation. From the NHS' perspective, it would avoid day case hospital admissions for lumbar punctures and readmissions to treat the common complication of post lumbar puncture headaches. This would create significant cost savings, when considering the significant number of patients undergoing this diagnostic process.
Datat
Verifikuar së fundmi: | 06/30/2019 |
Paraqitur së pari: | 06/11/2019 |
Regjistrimi i vlerësuar u dorëzua: | 07/16/2019 |
Postuar së pari: | 07/17/2019 |
Përditësimi i fundit i paraqitur: | 03/01/2020 |
Përditësimi i fundit i postuar: | 03/03/2020 |
Data e fillimit të studimit aktual: | 11/05/2019 |
Data e vlerësuar e përfundimit primar: | 04/30/2022 |
Data e vlerësimit të përfundimit të studimit: | 10/31/2022 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Diagnostic Test: Clinically isolated syndrome
Diagnostic Test: Clinically isolated syndrome
Faza
Grupet e krahëve
Krah | Ndërhyrja / trajtimi |
---|---|
Clinically isolated syndrome Those presenting for diagnositic evaluation of multiple sclerosis, not currently meeting the 2017 McDonald criteria. | Diagnostic Test: Clinically isolated syndrome Research T2* weighted MRI sequence |
Kriteret e pranimit
Moshat e pranueshme për studim | 18 Years Për të 18 Years |
Gjinitë e pranueshme për studim | All |
Metoda e marrjes së mostrës | Non-Probability Sample |
Pranon Vullnetarë të Shëndetshëm | po |
Kriteret | Inclusion Criteria: 1. Aged 18 to 65 years. 2. Presentation with a typical clinically isolated syndrome (Thompson et al. 2017) for diagnostic evaluation of MS. Exclusion Criteria: 1. Fulfils the diagnosis of MS, as defined by the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2017). 2. Unwilling or unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol. 3. Unable to provide informed consent. 4. Contraindication or inability to undergo MRI due to metal or metal implants, pregnancy, claustrophobia, pain, spasticity, or excessive movement related to tremor. |
Rezultati
Masat Kryesore të Rezultateve
1. The sensitivity of the central vein sign (CVS) on T2* MRI scan and lumbar puncture with oligoclonal band testing at diagnosing MS at the time of the patients' first presentation. [18 months]
Masat dytësore të rezultateve
1. The specificity of the central vein sign (CVS) on T2* MRI scan and lumbar puncture with oligoclonal band testing at diagnosing MS at the time of the patients' first presentation. [18 months]
2. The sensitivity and specificity of the 'rule of six' proposed in Mistry et al. 2016. [18 months]
Masat e tjera të rezultateve
1. The percentage agreement between blinded raters of the CVS amongst different observers. [18 months]
2. The sensitivity and specificity of combing the CVS with the results of the lumbar puncture. [18 months]
3. A sensitivity analysis, allowing for variation in test performance between sites, using a mixed effects logistic regression model. [18 months]
4. The sensitivity and specificity of the 3D FLAIR* (a research imaging technique) [18 months]