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Copeptin and the S-100b Protein in Stroke
| Condition or disease | Intervention/treatment |
|---|---|
| Vertigo, Peripheral Vertigo, Brain Stem Vertigo; Central Vertigo; Cerebral | Diagnostic Test: copeptin, PS100 |
Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo.
Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT [Head Impulse test, Nystagmus, test of skew deviation] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis.
| Study Type : | Observational |
| Actual Enrollment : | 151 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments |
| Actual Study Start Date : | May 1, 2016 |
| Actual Primary Completion Date : | January 31, 2018 |
| Actual Study Completion Date : | January 31, 2018 |
- Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo [ Time Frame: 1 hour ]negative predictive value of the S-100b protein and copeptin combination
Biospecimen Retention: Samples Without DNA
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 7, 2019 | ||||
| First Posted Date | June 5, 2019 | ||||
| Last Update Posted Date | June 5, 2019 | ||||
| Actual Study Start Date | May 1, 2016 | ||||
| Actual Primary Completion Date | January 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo [ Time Frame: 1 hour ] negative predictive value of the S-100b protein and copeptin combination
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Copeptin and the S-100b Protein in Stroke | ||||
| Official Title | Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments | ||||
| Brief Summary | This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI. | ||||
| Detailed Description |
Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo. Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT [Head Impulse test, Nystagmus, test of skew deviation] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
PS100 concentrations were measured on serum samples by electro-chemiluminescence assay (Roche, Mannheim, Germany). Copeptin concentrations were measured on serum samples by the Kryptor method (Thermo Scientific, Hennigsdorf, Germany)
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | One hundred and fifty-one patients were included, of whom 16 were secondarily excluded (lost to follow-up n=1, missing biomarkers n=9, missing MRI n=6)(Figure 1). A majority of the remaining 135 patients were women (n=79, 59%) with an average age of 62 years . Specialized advice on the origin of dizziness was sought from ENT and/or neurologist in 102 (76%) of cases. Patients received brain diffusion-weighted MRI alone in 74 cases, contrast brain CT alone in 11 cases and a combination of MRI and CT in 50 cases. In 122 patients (90%), vertigo was not related to stroke. | ||||
| Condition |
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| Intervention | Diagnostic Test: copeptin, PS100
Age, sex and time between dizziness onset and ED visit were collected using Resurgences® software. PS100 concentrations were measured on serum samples by electro-chemiluminescence assay. Copeptin concentrations were measured on serum samples by the Kryptor method. The positivity threshold for copeptin was set at strictly above 10 pmol/L and that of PS100 was set at strictly above 0.105 μmol/L. And after, we compared results with results of brain imaging: Magnetic Resonance Imaging alone, CT scan alone or both. Depending on clinical presentation, the imaging tests were performed during ED stay, during hospitalization or externally. Presence or absence of stroke was established on diffusion-weighted brain MRI . In case of normal contrast CT alone, a specialized opinion should exclude the need for diffusion-weighted MRI according to clinical presentation. |
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
151 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 31, 2018 | ||||
| Actual Primary Completion Date | January 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03974464 | ||||
| Other Study ID Numbers | vertigo | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Poitiers University Hospital | ||||
| Study Sponsor | Poitiers University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Poitiers University Hospital | ||||
| Verification Date | June 2019 | ||||
