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Pathophysiology of Central Apnoeas in Stroke Patients

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ClinicalTrials.gov Identifier: NCT01723189
Recruitment Status : Unknown
Verified November 2012 by MPons, Ospedale Civico, Lugano.
Recruitment status was:  Recruiting
First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Collaborators:
Advisory Board of scientific Reserch Ente Ospedaliero Cantonale, ABREOC
University of Geneva, Switzerland
University of Milan
Information provided by (Responsible Party):
MPons, Ospedale Civico, Lugano

Brief Summary:

40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.

Clinical studies conducted in patients with hearth failure and central apnoeas have demonstrated the pathogenetic central role of hypersensitivity of central and peripheral chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity of sympathetic nervous system.

The joint study of chemoreflexes and baroreflexes in patients with central apneas during the acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in literature, that should supply useful elements to clarify the pathogenesis and the clinical and prognostic significance of these disorders.

Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than patients with ischemic stroke not accompanied by respiratory problems and compared with healthy controls.


Condition or disease
Central Apnoeas Stroke Patients

Detailed Description:

Investigators expected to include in the study of 120 patients, aged between 35 and 75 years, belonging to the following diagnostic categories:

  • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
  • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
  • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
  • 30 healthy controls matched for age, sex, race and BMI.

For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the cardiac rate (RR interval) and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.

For the study of central chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of Oxygen partial pressure (PaO2). The ventilatory response to hypercapnia is calculated by the method of linear regression and is represented by the angular coefficient of the straight line that describes the variation of ventilation for each variation of alveolar carbon dioxide partial pressure (PCO2).

For the study of peripheral chemoreceptors will be used the single-breath or transient hypercapnia test. The patient makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. It is expected, therefore, a period of 3 seconds, required because the gases contained in the mixture may come from the pulmonary circulation to the peripheral circulation, at the level of peripheral chemoreceptors. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Central Apnoeas in the Course of Transient Ischemic Attack/Ischemic Stroke: Clinical, Prognostic, Pathophysiological Elements.
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Group/Cohort
Central Apnoeas Patients
• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
Obstructive apnoea patients
• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
No SDB patients
  • • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
Healthy controls
• 30 healthy controls matched for age, sex, race and BMI.



Primary Outcome Measures :
  1. Baroreflexes [ Time Frame: 3 months ]
    For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the RR interval and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.

  2. Chemoreflexes [ Time Frame: 3 months ]
    For the study of central and peripheral chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of PaO2, and the single-breath test in wich the subject makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.


Secondary Outcome Measures :
  1. Apnoea-hypopnoea index (AHI) [ Time Frame: 3 months ]
    Assessing prognosis and spontaneous temporal evolution of central apnoeas in patients with cerebral ischemic events.



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Patients

    • ≥35 years old and < 75 years old
    • with clinical diagnosis of TIA or ischemic stroke
    • admitted in a Stroke Unit within 2 days from onset of symptoms
    • signed Informed Consent

Exclusion Criteria:

  • Patients

    • with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
    • currently on continuous positive airway pressure (CPAP) or on CPAP during the last 3 months before stroke
    • with non-ischemic events (intracerebral/subarachnoid haemorrhage)
    • Patients with coma/stupor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723189


Contacts
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Contact: Marco Pons, Professor 0041-91-8116449 marco.pons@eoc.ch
Contact: Alessia Riglietti, MD 0041-91-8116317 alessia.riglietti@eoc.ch

Locations
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Switzerland
Ospedale Civico Recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Marco Pons, MD    +41 91 811 6449    marco.pons@eoc.ch   
Contact: Alessia Riglietti, MD    +41 91 811 6317    alessia.riglietti@eoc.ch   
Principal Investigator: Marco Pons, MD         
Sub-Investigator: Alessia Riglietti, MD         
Sponsors and Collaborators
MPons
Advisory Board of scientific Reserch Ente Ospedaliero Cantonale, ABREOC
University of Geneva, Switzerland
University of Milan
Investigators
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Principal Investigator: Marco Pons, MD Ospedale Regionale di Lugano - Civico

Additional Information:
Publications:

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Responsible Party: MPons, Professor, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier: NCT01723189     History of Changes
Other Study ID Numbers: EOC.NSI.12.04
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Keywords provided by MPons, Ospedale Civico, Lugano:
central apnoeas
stroke
Additional relevant MeSH terms:
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Apnea
Sleep Apnea, Central
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders