Coronary Artery DiseaseNCT03743090
Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)
An observational study of Coronary Artery Disease, run by Astes.
Trial summary
1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC). 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion. 3. ECC could influence the amount of intravenous perfusion administered to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Polysomnography.
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 10 Apr 2020
- 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: All of the patients scheduled for an elective CABG at the Clinique Saint-Luc of Bouge (Namur, Belgium).
Who may be able to join
- All of the patients scheduled for an elective CABG
Who cannot join
- Patient's refusal
About this study
- 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
- 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
- 3. ECC could influence the amount of intravenous perfusion administered to the patient.
The aim of this study was to examine the influence of ECC on the development of OSA.
Read the detailed description
- 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
- 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
- 3. ECC could influence the amount of intravenous perfusion administered to the patient.
The aim of this study was to examine the influence of ECC on the development of OSA. The AHI (Apnea Hypopnea Index) will be used to assess this potential influence.
- Conditions
- Coronary Artery Disease
- Being tested
- Polysomnography.
- Keywords
- coronary artery disease, obstructive sleep apnea
- Medical subject headings
- Coronary Artery Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography.Diagnostic test
A polysomnography will be performed for all of the patients the day before surgery (value of reference), and on the second postoperative day (in order to examine the influence of ECC on the development of OSA).
| Study group | Role | What they receive |
|---|---|---|
| CABG with ECC | Group of patients for whom CABG was performed under ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day. Receives: Diagnostic Test: Polysomnography. | |
| CABG without ECC | Group of patients for whom CABG was performed without ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day. Receives: Diagnostic Test: Polysomnography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the AHI
Change from baseline AHI (Apnea Hypopnea Index, which is the average amount of apnea and hypopnea per four of sleep) at the 3rd postoperative day. The AHI is derived from the polysomnography which will be performed to all of the patients the day before surgery and the 3rd postoperative day.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Aug 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion10 Apr 2020 (estimated)
Why it stopped: lack of PSG
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
- Investigators
- Eric DEFLANDRE, MD, PhD, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743090
- Sponsor's protocol ID
- OSACS
- Status last verified
- Jan 2020
- First submitted
- 13 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)
- ClinicalTrials.gov ID
- NCT03743090
- Acronym / sponsor ID
- OSACS
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of PSG
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 10 Apr 2020 (estimated)
- First posted
- 15 Nov 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.
- 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
- 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
- 3. ECC could influence the amount of intravenous perfusion administered to the patient.
The aim of this study was to examine the influence of ECC on the development of OSA.
Detailed description
- 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
- 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
- 3. ECC could influence the amount of intravenous perfusion administered to the patient.
The aim of this study was to examine the influence of ECC on the development of OSA. The AHI (Apnea Hypopnea Index) will be used to assess this potential influence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG with ECC | – | Diagnostic Test: Polysomnography.Group of patients for whom CABG was performed under ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day. |
| CABG without ECC | – | Diagnostic Test: Polysomnography.Group of patients for whom CABG was performed without ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients scheduled for an elective CABG at the Clinique Saint-Luc of Bouge (Namur, Belgium).
Key inclusion criteria (1 listed)
- All of the patients scheduled for an elective CABG
Key exclusion criteria (1 listed)
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysomnography.A polysomnography will be performed for all of the patients the day before surgery (value of reference), and on the second postoperative day (in order to examine the influence of ECC on the development of OSA). | Diagnostic test | CABG with ECC, CABG without ECC |
Primary outcome
Change in the AHI
Time frame: 3 days
Change from baseline AHI (Apnea Hypopnea Index, which is the average amount of apnea and hypopnea per four of sleep) at the 3rd postoperative day. The AHI is derived from the polysomnography which will be performed to all of the patients the day before surgery and the 3rd postoperative day.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Eric DEFLANDRE, MD, PhD principal investigator
Astes
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Astes.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the AHI (time frame: 3 days). 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 13 Jan 2020.