MUcociliary Clearance IN Stroke

NCT03884166 | Unknown

• 1 other identifier: MUCINS
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Acute Ischemic Stroke; Bronchoscopy

Outcome Measures

Primary Outcomes (2)

• Mucociliary Clearance

  \- number of cilia (scanning electron microscopy)

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

• Mucociliary Clearance

  \- activity of cilia given as frequency (in-vivo optical coherence tomography)

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

Secondary Outcomes (8)

• Occurence of stroke-associated pneumonia

  7 days after stroke

• Activity of autonomous nervous system

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

• Activity of immune System - Concentration of cytokines

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

• Activity of immune System - Concentration of inflammatory markers

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

• Activity of immune System - Expression of HLA-DR

  at time of bronchoscopy (within 2 weeks after acute ischemic stroke)

Study Arms (2)

stroke

Diagnostic Test: bronchoscopy

control

Diagnostic Test: bronchoscopy

Interventions

bronchoscopy DIAGNOSTIC_TEST

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

control; stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator
• Department of Infectiology and Pneumonology, Charite, Berlin: collaborator
• University of Giessen: collaborator
• University of Luebeck: collaborator
• Labor Berlin - Charité Vivantes GmbH: collaborator

Study Sites (1)

NeuroCure Clinical Research Center (NCRC), Charité

Mitte, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Andreas Meisel, Prof. Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Meisel, Prof. Dr. med.

CONTACT

+49 30 450 560026; andreas.meisel@charite.de

Benjamin Hotter, Dr. med.

CONTACT

+49 30 450 639729; benjamin.hotter@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: June 30, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

DE (1)