Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation
2021年9月27日 更新者：Kristofer Hedman、Linkoeping University
Lung Function, Heart Function and Aerobic Capacity in Patients Suffering From Long-term Symptoms Following SARS-CoV2-infection, and the Association With DNA Methylation
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated.
This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound.
Patients' symptoms will be correlated to physiological measures and compared to predicted values.
In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns.
In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
研究概览
详细说明
The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.
This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.
In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.
研究类型
观察性的
注册 (预期的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Östergötland
-
Linköping、Östergötland、瑞典、58737
- 招聘中
- Dept Health, Medicine and Caring Sciences
-
接触：
- Kristofer Hedman, MD, PhD
- 电话号码：+46704897941
- 邮箱：kristofer.hedman@liu.se
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All subjects fulfilling inclusion criteria and no exclusion criterion referred for a clinical examination at the specified clinic will be informed about the study and inquired regarding participation.
描述
Inclusion Criteria:
- Confirmed or clinically highly suspected Covid19-infection
- Symptom duration at least 12 weeks following first occurence of symptoms
- No other disease that better could explain the symptoms than Covid19
Exclusion Criteria:
- Age <18 years
- Unability to perform a maximal exercise test
- Unability to understand written or spoken Swedish
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Covid19
Patients aged >18 years with confirmed Covid19 disease with symptoms >12 weeks, not better explained by other disease
|
Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography.
20 subjects will perform DNA-methylation testing.
|
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 |
|---|---|---|
|
Peak Oxygen Consumption (VO2peak)
大体时间：At baseline
|
Cross-sectional evaluation of VO2peak and the association with symptoms
|
At baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peak Oxygen Consumption (VO2peak)
大体时间：In subset of subjects at 1 year
|
Improvement in VO2peak over 1 year
|
In subset of subjects at 1 year
|
|
VE/VCO2-slope
大体时间：At baseline, in subset at 1 year
|
Cross-sectional evaluation of VE/VCO2 and the association with symptoms
|
At baseline, in subset at 1 year
|
|
Diffusion Capacity (DLCOc)
大体时间：At baseline, in subset at 1 year
|
Cross-sectional evaluation of DLCOc and the association with symptoms
|
At baseline, in subset at 1 year
|
|
Forced Expiratory Volume in 1 second (FEV1)
大体时间：At baseline, in subset at 1 year
|
Cross-sectional evaluation of FEV1 and the association with symptoms
|
At baseline, in subset at 1 year
|
|
Forced Vital Capacity (FVC)
大体时间：At baseline, in subset at 1 year
|
Cross-sectional evaluation of FVC and the association with symptoms
|
At baseline, in subset at 1 year
|
|
Total Lung Capacity (TLC)
大体时间：At baseline, in subset at 1 year
|
Cross-sectional evaluation of TLC and the association with symptoms
|
At baseline, in subset at 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月20日
初级完成 (预期的)
2022年6月1日
研究完成 (预期的)
2022年6月1日
研究注册日期
首次提交
2021年4月13日
首先提交符合 QC 标准的
2021年4月21日
首次发布 (实际的)
2021年4月26日
研究记录更新
最后更新发布 (实际的)
2021年10月4日
上次提交的符合 QC 标准的更新
2021年9月27日
最后验证
2021年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2021-01620
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
As part of a national collaboration on Post Covid19, coded (deidentified) data may be shared with other selected researchers in accordance with the ethical permission obtained by the Ethical Review Board.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.