Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)
2019年6月5日 更新者：Alexander H Nave、Charite University, Berlin, Germany
Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe): Protocol of an Observational Study Accompanying a Randomized Controlled Trial
The purpose of this observational study is to examine the effects of 4-weeks of physical fitness training in patients with subacute ischemic stroke on cerebral imaging and blood-derived biomarkers.
研究概览
地位
完全的
条件
详细说明
This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled trial "Physical Fitness Training in Subacute Stroke" (PHYS-STROKE).
In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4-weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4-weeks of relaxation sessions (5 times a week, for 50 minutes).
A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and blood tests before and after the PHYS-STROKE intervention.
Imaging scans will address parameters of cerebral perfusion and vessel size imaging.
Blood tests will determine several parameters such as immunity, inflammation (including neopterin, MMP-9), metabolism (including ApoCIII, oxidized LDL, HOMA-index, uric acid, CK-MB, cystatin c, and leptin), cytokines (osteopontin, adiponectin), and endothelial function (SDF1-alpha, ADMA, sICAM, sVCAM, E-selectin, P-selectin).
Additionally, we will assess the association between functional outcomes (co-primary outcome measures of PHYS-STROKE) and biomarkers including imaging results.
研究类型
观察性的
注册 (实际的)
100
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
-
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Berlin、德国、10117
- Charité - Universitätsmedizin Berlin
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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
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.
描述
Inclusion Criteria:
- Age: > 18 years
- Diagnosis of subacute ischemic stroke (within 5-45 days after stroke onset)as determined by initial MRI/CT scan of the brain
- Cortical, sub-cortical, or brainstem affection
- Barthel Index (BI) <65 at inclusion
- Able to sit for at least 30 seconds (unsupported or supported, i.e., holding onto supports such as the edge of the bed)
- Ability to perform aerobic exercise, determined by by responsible physician
- Provision of written informed consent
Exclusion Criteria:
- Lacking ability to comply with study requirements
- Stroke due to intracranial haemorrhage
- Previous subarachnoid hemorrhage or other hemorrhagic stroke
- Progressive stroke
- Not able to receive magnetic resonance imaging scans, including perfusion imaging
- Unable to perform the required exercises due to medical, musculoskeletal, or neurological problems
- Required help of at least 1 person to walk before stroke due to neurological (e. g., advanced Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis) or non-neurological co-morbidities (e. g. heart failure, orthopaedic problems)
- Life expectancy < 1 year as determined by responsible physician
- Drug or alcohol addiction within the last six months
- Significant current psychiatric illness defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
- Current participation in another interventional trial
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 |
|---|
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Physical Fitness
Patients from this group underwent 4 weeks of aerobic fitness training additional to normal supportive care, 5 times a week, for 50 minutes
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Relaxation
Patients of this group received 4-weeks of relaxation sessions additional to normal supportive care, 5 times a week, for 50 minutes.
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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 |
|---|---|---|
|
Cerebral perfusion
大体时间：baseline and 4-weeks
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Magnetic resonance imaging (MRI)-based cerebral perfusion are assessed before and after the 4-weeks of physical fitness training. Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients. |
baseline and 4-weeks
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Blood-derived biomarkers
大体时间：baseline and 4-weeks
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Changes in blood biomarkers are assessed before and after the 4-weeks intervention of physical fitness training. Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients. |
baseline and 4-weeks
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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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next cerebrovascular event
大体时间：6 months
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Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke
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6 months
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functional outcome
大体时间：directly after the end of intervention and 3 months post stroke
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functional outcome assessed via functional scores such as Barthel Index and walking speed (co-primary endpoints of PHYS-STROKE) as well as the modified Rankin Scale (mRS)
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directly after the end of intervention and 3 months post stroke
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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functional outcome
大体时间：3 months
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Analyzing how changes in imaging measures and blood-derived biomarkers are related to each other and to differences in functional outcome, in particular gait speed, Barthel index (co-primary endpoints of PHYS-STROKE) and modified Rankin Scale
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3 months
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endothelial function assessment
大体时间：measurement before and after the 4 weeks intervention
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the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device.
First measurement was conducted in January 11th 2014.
Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups.
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measurement before and after the 4 weeks intervention
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Clinical biomarkers including vital Parameters
大体时间：measurements at baseline and all follow-up time points (measurement before and after the 4 weeks intervention, at 3 months and at 6 months after stroke)
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systolic and diastolic blood pressure, resting heart rate, body-mass-index, and waist-to-hip-ratio over time compared between study groups
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measurements at baseline and all follow-up time points (measurement before and after the 4 weeks intervention, at 3 months and at 6 months after stroke)
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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。
调查人员
- 首席研究员：Martin Ebinger, MD、Center for Stroke Research Berlin
- 首席研究员：Alexander H Nave, MD、Center for Stroke Research Berlin
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Jodicke RA, Huo S, Krankel N, Piper SK, Ebinger M, Landmesser U, Floel A, Endres M, Nave AH. The Dynamic of Extracellular Vesicles in Patients With Subacute Stroke: Results of the "Biomarkers and Perfusion-Training-Induced Changes After Stroke" (BAPTISe) Study. Front Neurol. 2021 Nov 8;12:731013. doi: 10.3389/fneur.2021.731013. eCollection 2021.
- Muller S, Kufner A, Dell'Orco A, Rackoll T, Mekle R, Piper SK, Fiebach JB, Villringer K, Floel A, Endres M, Ebinger M, Nave AH. Evolution of Blood-Brain Barrier Permeability in Subacute Ischemic Stroke and Associations With Serum Biomarkers and Functional Outcome. Front Neurol. 2021 Oct 20;12:730923. doi: 10.3389/fneur.2021.730923. eCollection 2021.
- Nave AH, Krober JM, Brunecker P, Fiebach JB, List J, Grittner U, Endres M, Meisel A, Floel A, Ebinger M. Biomarkers and perfusion--training-induced changes after stroke (BAPTISe): protocol of an observational study accompanying a randomized controlled trial. BMC Neurol. 2013 Dec 11;13:197. doi: 10.1186/1471-2377-13-197.
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)
2013年10月1日
初级完成 (实际的)
2017年7月1日
研究完成 (实际的)
2017年11月1日
研究注册日期
首次提交
2013年9月27日
首先提交符合 QC 标准的
2013年10月4日
首次发布 (估计)
2013年10月7日
研究记录更新
最后更新发布 (实际的)
2019年6月7日
上次提交的符合 QC 标准的更新
2019年6月5日
最后验证
2019年6月1日
更多信息
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.