Microparticles in Obstructive Sleep Apnea (BioSAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Wojciech Trzepizur, MD; Phone Number: +33 0680575272; Email: wotrzepizur@chu-angers.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
    • Contact: Wojciech Trzepizur, MD; Phone Number: +33 0680575272; Email: wotrzepizur@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with prevalent cardiovascular diseases referred to a sleep clinic for suspected OSA.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy
• previously treated OSA

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): February 20, 2026
• Study Completion (Anticipated): February 20, 2026

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: cardiovascular outcomes; microparticles
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2017-A02494-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No