Microparticles in Obstructive Sleep Apnea

NCT03438149 | Recruiting

• 1 other identifier: 2017-A02494-49
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

microparticles; cardiovascular outcomes

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• pregnancy
• previously treated OSA

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

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

Angers, 49100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Wojciech Trzepizur, MD

CONTACT

0680575272; wotrzepizur@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: February 20, 2018
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

FR (1)