MUcociliary Clearance IN Stroke

NCT ID: NCT03884166

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Stroke, Ischemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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stroke

bronchoscopy

Intervention Type DIAGNOSTIC_TEST

Patients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance

control

bronchoscopy

Intervention Type DIAGNOSTIC_TEST

Patients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance

Interventions

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bronchoscopy

Patients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroCure Clinical Research Center, Charite, Berlin

OTHER

Sponsor Role collaborator

Department of Infectiology and Pneumonology, Charite, Berlin

UNKNOWN

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role collaborator

Labor Berlin - Charité Vivantes GmbH

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Meisel

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Meisel, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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NeuroCure Clinical Research Center (NCRC), Charité

Mitte, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Meisel, Prof. Dr. med.

Role: CONTACT

+49 30 450 560026

Benjamin Hotter, Dr. med.

Role: CONTACT

+49 30 450 639729

Facility Contacts

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Andreas Meisel, Prof. Dr. med.

Role: primary

+49 30 450 560026

Benjamin Hotter, Dr. med.

Role: backup

+49 30 450 639 729

Other Identifiers

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MUCINS

Identifier Type: -

Identifier Source: org_study_id

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