Microparticles in Obstructive Sleep Apnea

NCT ID: NCT03438149

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2026-02-20

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• previously treated OSA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Wojciech Trzepizur, MD

Role: CONTACT

wotrzepizur@chu-angers.fr

0680575272 ext. +33

Facility Contacts

Wojciech Trzepizur, MD

Role: primary

wotrzepizur@chu-angers.fr

0680575272 ext. +33

Other Identifiers

2017-A02494-49

Identifier Type: -

Identifier Source: org_study_id