MUcociliary Clearance IN Stroke
- Conditions
- Stroke, Ischemic
- Interventions
- Diagnostic Test: bronchoscopy
- Registration Number
- NCT03884166
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Stroke patients frequently suffer from stroke associated pneumonia. Pathophysiologically speaking, dysphagia and central nervous system (CNS)-injury induced immunosuppression largely contribute to the risk for pneumonia. In mouse models for stroke, the self-cleaning mechanisms of the lung are also affected by stroke, possibly further contributing to this risk.
The investigators designed a pilot-study to examine the structural and functional integrity of the self-cleaning mechanisms of the lung in stroke patients.
- Detailed Description
Survival and functional outcome of stroke is strongly depending on the occurence of pneumonia (stroke-associated pneumonia, SAP). Early diagnose and treatment of SAP is paramount in the treatment of stroke patients. While dysphagia strongly contributes to its pathogenesis, recent years have also shown a strong risk-modulation by CNS injury induced immunosuppression, making stroke patients more susceptible to SAP. Additionally, murine models of stroke showed changes in mucociliary clearance as possible contributors to SAP. It remains unclear, whether structural integrity and mucociliary clearance of the respiratory epithel change in stroke patients, and whether these changes might contribute to the occurence of SAP.
Therefore, the investigators designed this exploratory observational pilot-study to examine the structural and functional integrity of respiratory epithel in severely affected stroke patients and correlate these findings to immune phenotyping and occurence of SAP. The investigators will conduct bronchoscopy in severely affected stroke patients to collect histological samples in order to evaluate multiple tissue predictors, as well as perform optical coherence tomography to examine ciliary kinetics in-vivo. The investigators will furthermore perform serum and plasma immune phenotyping, record occuring pneumonias and correlate these data in order to identify possible predictors of pneumonia.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- Age ≥18 years
- Informed consent signed by patient or legal representatives
- Acute ischemic stroke within the past 2 weeks (except the control group)
- Indication for diagnostic or therapeutic bronchoscopy
- Confirmed lung malignancies or specific inflammations of the lungs
- Pneumonia (only control group)
- Autoimmune diseases of respiratory system (only control group)
- Chronic inflammatory diseases of respiratory system (only control group)
- chronic obstructive pulmonary disease (COPD) and spastic diseases of respiratory system (only control group)
- Patients being committed to psychiatric institutions or prisons
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description stroke bronchoscopy - control bronchoscopy -
- Primary Outcome Measures
Name Time Method Mucociliary Clearance at time of bronchoscopy (within 2 weeks after acute ischemic stroke) - activity of cilia given as frequency (in-vivo optical coherence tomography)
- Secondary Outcome Measures
Name Time Method Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Autophagy at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Intensity of fluorescence of Light chain (LC) 3b protein, Aurora A and Human enhancer of filamentation (HEF)1
Activity of autonomous nervous system at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Concentration of Cortisol, Adrenaline and Noradrenaline in blood and heart frequency variability
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Apoptosis at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Intensity of fluorescence of TUNEL
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Increase of secretory cells at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Expression levels of surfactant protein, Muc5a, SPDEF, Foxa3
Activity of immune System - Expression of HLA-DR at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Expression of Human Leukocyte Antigens (HLA)-DR on monocytes in antigens/cell
Occurence of stroke-associated pneumonia 7 days after stroke Pneumonia is defined according to the consensus recommendations (Smith et al., Stroke 2015)
Activity of immune System - Concentration of cytokines at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Concentration of cytokines (IL-6, IL-13 and more) in blood
Activity of immune System - Concentration of inflammatory markers at time of bronchoscopy (within 2 weeks after acute ischemic stroke) Concentration of inflammatory markers (PCT, CRP) in blood
Trial Locations
- Locations (1)
NeuroCure Clinical Research Center (NCRC), Charité
🇩🇪Berlin-Mitte, Germany