Microparticles in Obstructive Sleep Apnea

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03438149

Acronym

BioSAS

Enrollment

300

Registered

2018-02-19

Start date

2018-02-20

Completion date

2026-02-20

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

microparticles, cardiovascular outcomes

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* pregnancy * previously treated OSA

Design outcomes

Primary

Measure	Time frame	Description
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
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
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

Countries

France

Contacts

Primary ContactWojciech Trzepizur, MD

wotrzepizur@chu-angers.fr0680575272

Outcome results