Microparticles in Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— BioSAS  

Official title:

Microparticles as a Biomarker of Incident Cardiovascular Risk in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03438149
• Other study ID #: 2017-A02494-49
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: February 20, 2026

Study information

• Verified date: January 2019
• Source: University Hospital, Angers
• Contact: Wojciech Trzepizur, MD
• Phone: 0680575272
• Email: wotrzepizur[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of coronary artery disease or cerebrovascular disease

• diagnosis of moderate-to-severe OSA

Exclusion Criteria:

• pregnancy

• previously treated OSA

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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