Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)
Long-term Neurological Outcome After SARS-CoV-2 Infection
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
Tyrol
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Innsbruck、Tyrol、オーストリア、6020
- 募集
- Medical University Innsbruck, Department of Neurology
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コンタクト:
- Raimund Helbok, Priv.Doz. Dr.
- 電話番号:81689 +43 50 504
- メール:raimund.helbok@tirol-kliniken.at
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
C healthy
Healthy control group
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No Intervention takes place, Patients are being observed and classified according to disease severity
他の名前:
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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
他の名前:
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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
他の名前:
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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
他の名前:
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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
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prevalence of neurological manifestations in COVID-19 patients
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
時間枠: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.
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KLI 986
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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