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Is Obstructive Sleep Apnoea a Risk Factor for Thoracic Aortic Aneurysm Expansion? A Prospective Cohort Study.

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ClinicalTrials.gov Identifier: NCT02204774
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Study Description
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Brief Summary:
The objective of this prospective cohort study in patients with a known thoracic aortic aneurysm is to test the hypothesis that yearly aneurysm progression rate is higher in patients with obstructive sleep apnoea (OSA) compared to patients without OSA, and that the need for aortic operation or proven or presumed death from aortic rupture or dissection happens more often in patients with thoracic aortic aneurysm and OSA compared to patients without OSA.

Condition or disease
Aortic Aneurysm Obstructive Sleep Apnea

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Study Design
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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Obstructive Sleep Apnoea a Risk Factor for Thoracic Aortic Aneurysm Expansion? A Prospective Cohort Study.
Study Start Date : July 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Groups and Cohorts
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Group/Cohort
Dilatated or aneurysmatic Aorta
Complete cohort, which will be followed over 3 years


Outcome Measures
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Primary Outcome Measures :
  1. Aneurysm expansion rate [ Time Frame: three years ]
    mm per year


Secondary Outcome Measures :
  1. combined endpoint of operation (or fulfilling the criteria for operation) [ Time Frame: three years ]
    Operation

  2. endovascular repair because of rapid progression of thoracic aortic aneurysm [ Time Frame: three years ]
    >10 mm per year and/or an aneurysm diameter >50 to 60 mm

  3. Death from proven or presumed aortic dissection/rupture [ Time Frame: three years ]
    Death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of thoracic aortic aneurysm defined by the following parameters

  • Women: at the level of the sinus of valsalva >39mm, or ascending aorta >42mm.
  • Men: at the level of the sinus of valsalva >44mm, or ascending aorta >46mm.
Criteria

Inclusion criteria:

  1. Diagnosis of thoracic aortic aneurysm defined by the following parameters

    • Women: at the level of the sinus of valsalva >39mm, or ascending aorta >42mm.
    • Men: at the level of the sinus of valsalva >44mm, or ascending aorta >46mm.
  2. Age > 18 years.

Exclusion Criteria:

  1. Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.
  2. Patients with known central sleep apnoea.
  3. Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.
  4. Patients with moderate or severe aortic regurgitation.
  5. Patients with moderate or severe aortic stenosis.
  6. Pregnant patients.
Contacts and Locations
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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): NCT02204774


Locations
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Switzerland
University Hospital Zurich, Pneumology
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Study Director: Malcolm Kohler, MD Universuty of Zurich
More Information
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Responsible Party: Malcolm Kohler, Head, Division of Pneumology, University of Zurich
ClinicalTrials.gov Identifier: NCT02204774     History of Changes
Obsolete Identifiers: NCT02162108
Other Study ID Numbers: V 1.1
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by Malcolm Kohler, University of Zurich:
aortic aneurysm
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases