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

NCT02204774 | Completed

• 1 other identifier: V 1.1
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm; Obstructive Sleep Apnea

Keywords

aortic aneurysm; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Aneurysm expansion rate

  mm per year

  three years

Secondary Outcomes (3)

• combined endpoint of operation (or fulfilling the criteria for operation)

  three years

• endovascular repair because of rapid progression of thoracic aortic aneurysm

  three years

• Death from proven or presumed aortic dissection/rupture

  three years

Study Arms (1)

Dilatated or aneurysmatic Aorta

Complete cohort, which will be followed over 3 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Age \> 18 years.

You may not qualify if:

• Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.
• Patients with known central sleep apnoea.
• Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.
• Patients with moderate or severe aortic regurgitation.
• Patients with moderate or severe aortic stenosis.
• Pregnant patients.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pneumology

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Gaisl T, Rejmer P, Roeder M, Baumgartner P, Sievi NA, Siegfried S, Stampfli SF, Thurnheer R, Stradling JR, Tanner FC, Kohler M. Obstructive sleep apnoea and the progression of thoracic aortic aneurysm: a prospective cohort study. Eur Respir J. 2021 May 6;57(5):2003322. doi: 10.1183/13993003.03322-2020. Print 2021 May.

  PMID: 33214207 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Malcolm Kohler, MD

  Universuty of Zurich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Pneumology

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 30, 2014
• Study Start: July 5, 2014
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CH (1)