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RecruitingNCT03438149BioSASUpdated Jan 16, 2019

Microparticles in Obstructive Sleep Apnea

An observational study in Sleep Apnea, Obstructive, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Apnea, Obstructive

Keywords

  • microparticles
  • cardiovascular outcomes
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • previously treated OSA
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. death from any cardiovascular cause

    outcomes assessed every year at the follow up visit or by calling the primary care physician

    Time frame: first event within 5 years after inclusion

  2. 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

    Time frame: first event within 5 years after inclusion

  3. cerebrovascular infarction (stroke or transient ischemic attack)

    outcomes assessed every year at the follow up visit or by calling the primary care physician

    Time frame: first event within 5 years after inclusion

  4. hospitalization for heart failure

    outcomes assessed every year at the follow up visit or by calling the primary care physician

    Time frame: first event within 5 years after inclusion

06

Study locations

1 of 1 sites recruiting
  • Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
    Angers, 49100, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03438149
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Feb 20, 2018
Primary completion
Feb 20, 2026 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Jan 16, 2019

Study contacts

Wojciech Trzepizur, MD
Contact
wotrzepizur@chu-angers.fr
0680575272 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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