Microparticles in Obstructive Sleep Apnea

Recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT03438149
• Lead Sponsor: University Hospital, Angers

Brief Summary

Obstructive sleep apnea (OSA) is independently associated with cardiovascular diseases, including myocardial infarction and stroke. OSA may promote atherosclerosis risk factors such as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the vascular wall. A growing number of studies have recently focused on the role of microparticles (MPs) in the atherogenic process. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA and that leukocyte-derived MP are released during the night in OSA. Furthermore, experimental evidence shows that MPs from OSA patients induce endothelial dysfunction.

The objective of this prospective study is to evaluate the impact of increased levels of leukocyte derived MPs on the cardiovascular outcomes in patients with prevalent cardiovascular diseases investigated for OSA.

Detailed Description

MPs are small plasma membrane vesicles that can be released by a variety of vascular or blood cells and that contain membrane and cytosolic elements. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA. Experimental evidence shows that MPs from OSA patients induce endothelial dysfunction, inflammation, and vascular hyperreactivity when injected to mice.

The impact of increased levels of MPs on the cardiovascular prognosis in OSA patient with prevalent cardiovascular diseases in unknown.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-02-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2026-02-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• diagnosis of coronary artery disease or cerebrovascular disease
• diagnosis of moderate-to-severe OSA

Exclusion Criteria

• pregnancy
• previously treated OSA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
myocardial infarction (acute infarct or silent myocardial infarction or unstable angina)	first event within 5 years after inclusion	outcomes assessed every year at the follow up visit or by calling the primary care physician
cerebrovascular infarction (stroke or transient ischemic attack)	first event within 5 years after inclusion	outcomes assessed every year at the follow up visit or by calling the primary care physician
death from any cardiovascular cause	first event within 5 years after inclusion	outcomes assessed every year at the follow up visit or by calling the primary care physician
hospitalization for heart failure	first event within 5 years after inclusion	outcomes assessed every year at the follow up visit or by calling the primary care physician

Trial Locations

Locations (1)

Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers; 🇫🇷 Angers, France