Stroke, IschemicMUCINSNCT03884166
MUcociliary Clearance IN Stroke
An observational study of Stroke, Ischemic, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- bronchoscopy
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jun 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the observational cohort consists of severely affected stroke patients, which require diagnostic or therapeutic bronchoscopy, from within out academic stroke center (mostly from the interdisciplinary neurological-neurosurgical intensive care unit). The control group will consist of neurologically healthy individuals presenting for standard bronchoscopy for any reason, i.e. diagnostic exclusion of malignoma. These will be recruited from an academic pneumologic center. Our center is located in the metropolitan area of Berlin. Due to the exploratory, "pilot" characteristics of this study, there will be no targeted inclusion in terms of age or gender, but we aim for a representative sample.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
NeuroCure Clinical Research Center (NCRC), Charité
Mitte, 10117
Andreas Meisel, Prof. Dr. med., +49 30 450 560026, andreas.meisel@charite.de
Benjamin Hotter, Dr. med., +49 30 450 639 729, benjamin.hotter@charite.de
About this study
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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- bronchoscopy
- Keywords
- Acute Ischemic Stroke, Bronchoscopy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopyDiagnostic test
Patients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance
| Study group | Role | What they receive |
|---|---|---|
| stroke | Not described Receives: Diagnostic Test: bronchoscopy | |
| control | Not described Receives: Diagnostic Test: bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucociliary Clearance
- number of cilia (scanning electron microscopy)
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Mucociliary Clearance
- activity of cilia given as frequency (in-vivo optical coherence tomography)
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Secondary outcomes (8)
Occurence of stroke-associated pneumonia
Pneumonia is defined according to the consensus recommendations (Smith et al., Stroke 2015)
Measured: 7 days after stroke
Activity of autonomous nervous system
Concentration of Cortisol, Adrenaline and Noradrenaline in blood and heart frequency variability
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Concentration of cytokines
Concentration of cytokines (IL-6, IL-13 and more) in blood
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Concentration of inflammatory markers
Concentration of inflammatory markers (PCT, CRP) in blood
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Expression of HLA-DR
Expression of Human Leukocyte Antigens (HLA)-DR on monocytes in antigens/cell
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Autophagy
Intensity of fluorescence of Light chain (LC) 3b protein, Aurora A and Human enhancer of filamentation (HEF)1
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Apoptosis
Intensity of fluorescence of TUNEL
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Increase of secretory cells
Expression levels of surfactant protein, Muc5a, SPDEF, Foxa3
Measured: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start30 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Infectiology and Pneumonology, Charite, Berlin, University of Giessen, University of Luebeck, Labor Berlin - Charité Vivantes GmbH
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884166
- Sponsor's protocol ID
- MUCINS
- Acronym
- MUCINS
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUcociliary Clearance IN Stroke
- ClinicalTrials.gov ID
- NCT03884166
- Acronym / sponsor ID
- MUCINS / MUCINS
- Conditions
- Stroke, Ischemic
- Keywords
- Acute Ischemic Stroke, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Infectiology and Pneumonology, Charite, Berlin, University of Giessen, University of Luebeck, Labor Berlin - Charité Vivantes GmbH
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke | – | Diagnostic Test: bronchoscopy |
| control | – | Diagnostic Test: bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the observational cohort consists of severely affected stroke patients, which require diagnostic or therapeutic bronchoscopy, from within out academic stroke center (mostly from the interdisciplinary neurological-neurosurgical intensive care unit). The control group will consist of neurologically healthy individuals presenting for standard bronchoscopy for any reason, i.e. diagnostic exclusion of malignoma. These will be recruited from an academic pneumologic center. Our center is located in the metropolitan area of Berlin. Due to the exploratory, "pilot" characteristics of this study, there will be no targeted inclusion in terms of age or gender, but we aim for a representative sample.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopyPatients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance | Diagnostic test | control, stroke |
Primary outcome
Mucociliary Clearance
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
- number of cilia (scanning electron microscopy)
Mucociliary Clearance
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
- activity of cilia given as frequency (in-vivo optical coherence tomography)
8 secondary outcomes
Occurence of stroke-associated pneumonia
Time frame: 7 days after stroke
Activity of autonomous nervous system
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Concentration of cytokines
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Concentration of inflammatory markers
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Activity of immune System - Expression of HLA-DR
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Autophagy
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Apoptosis
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Structural changes in respiratory tissue (nasal, tracheal and bronchial) - Increase of secretory cells
Time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Meisel, Prof. Dr. med. (+49 30 450 560026, andreas.meisel@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucociliary Clearance (time frame: at time of bronchoscopy (within 2 weeks after acute ischemic stroke)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.