Sleep Apnea, ObstructiveBioSASNCT03438149
Microparticles in Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2018to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with prevalent cardiovascular diseases referred to a sleep clinic for suspected OSA.
Who may be able to join
- diagnosis of coronary artery disease or cerebrovascular disease
- diagnosis of moderate-to-severe OSA
Who cannot join
- pregnancy
- previously treated OSA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
Angers, 49100
Wojciech Trzepizur, MD, 0680575272 ext. +33, wotrzepizur@chu-angers.fr
About this study
Official title: 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.
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.
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- microparticles, cardiovascular outcomes
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
death from any cardiovascular cause
outcomes assessed every year at the follow up visit or by calling the primary care physician
Measured: 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
Measured: 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
Measured: 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
Measured: first event within 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Feb 2018
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438149
- Sponsor's protocol ID
- 2017-A02494-49
- Acronym
- BioSAS
- Status last verified
- Jan 2019
- First submitted
- 2 Feb 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles as a Biomarker of Incident Cardiovascular Risk in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03438149
- Acronym / sponsor ID
- BioSAS / 2017-A02494-49
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- microparticles, cardiovascular outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with prevalent cardiovascular diseases referred to a sleep clinic for suspected OSA.
Key inclusion criteria (2 listed)
- diagnosis of coronary artery disease or cerebrovascular disease
- diagnosis of moderate-to-severe OSA
Key exclusion criteria (2 listed)
- pregnancy
- previously treated OSA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death from any cardiovascular cause
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: first event within 5 years after inclusion
outcomes assessed every year at the follow up visit or by calling the primary care physician
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Trzepizur, MD (0680575272 ext. +33, wotrzepizur@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death from any cardiovascular cause (time frame: first event within 5 years after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 1 Nov 2026.