Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)
Long-term Neurological Outcome After SARS-CoV-2 Infection
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Tyrol
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Innsbruck、Tyrol、奥地利、6020
- 招聘中
- Medical University Innsbruck, Department of Neurology
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接触:
- Raimund Helbok, Priv.Doz. Dr.
- 电话号码:81689 +43 50 504
- 邮箱:raimund.helbok@tirol-kliniken.at
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
Exclusion Criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
Specific Inclusion/exclusion criteria for the MRI substudy
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
- (6) definite contraindication to MRI (e.g. pacemakers)
Controls Patients after pneumonia (Cpneum) We will enrol at least 50 hospitalized age- and sex matched patients with pneumonia based on disease severity during the acute disease as: (group One) hospitalized (moderate; n=25) and (group two) severe patients admitted to the ICU for mechanical ventilation (n=25).
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) bacterial pneumonia according to CDC criteria,
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines, and
- (4) being able to speak and understand the German language,
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) definite contraindication to MRI (e.g. pacemakers)
Healthy referents (Chealthy) Currently n=38 MRI acquisitions of prospectively recruited healthy individuals are available, fulfilling the criteria of this proposal (age- and sex matched; same MR protocol). This cohort will be prospectively extended by n=42 to reach age and sex matched criteria.
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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C healthy
Healthy control group
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No Intervention takes place, Patients are being observed and classified according to disease severity
其他名称:
|
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C pneum
Control group of patients who were hospitalised and diagnosed with pneumonia ( COVID-19 pneumonia excluded)
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No Intervention takes place, Patients are being observed and classified according to disease severity
其他名称:
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Mild
Outpatients presenting to the hospital with COVID-19
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No Intervention takes place, Patients are being observed and classified according to disease severity
其他名称:
|
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Moderate
In-patients with COVID-19 not requiring ICU admission
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No Intervention takes place, Patients are being observed and classified according to disease severity
其他名称:
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Severe
Patients with COVID-19 admitted to the ICU
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No Intervention takes place, Patients are being observed and classified according to disease severity
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of neurological manifestations in COVID-19 patients
大体时间:3-months
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3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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3-months
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Prevalence of neurological manifestations in COVID-19 patients
大体时间:12-months
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12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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12-months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
大体时间:3-months
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Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 3-months after acute disease.
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3-months
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Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.
大体时间:12-months
|
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 12-months after acute disease.
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12-months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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