Recent Acute Myocardial InfarctionSAS-IDMNCT02439294
Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction
A study testing Without Obstructive Sleep Apnea (syndrome), Mild or moderate Obstructive Sleep Apnea (syndrome) and Severe Obstructive Sleep Apnea (syndrome) in people with Recent Acute Myocardial Infarction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Recent Acute Myocardial Infarction
- What is being tested?
- Without Obstructive Sleep Apnea (syndrome), Mild or moderate Obstructive Sleep Apnea (syndrome) and Severe Obstructive Sleep Apnea (syndrome)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2015to 5 Mar 2021
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures,
- Adults, men and women aged < 90 years,
- Hospitalized in Intensive Care Units, MI confirmed by the study of the coronary arteries (coronary angiography) in acute phase (primary coronary angiography) or secondarily (ambulatory IDM IDM initially reperfused by thrombolysis),
- Myocardial infarction defined the criteria normally applied (STEMI: ST segment depression greater than 2 mm in at least 2 contiguous leads or new onset of pain and a left bundle branch block),
- The score of delayed enhancement MRI should be greater than 5 segments of 17 during the first MRI (criterion of severity of AMI),
- The subject must be affiliated to a social security scheme
Who cannot join
- Patients for whom CPAP equipment has demonstrated its usefulness regardless of cardiovascular context
- Patients sleepy (Epworth score> 13)
- Road Truckers
- Contraindication to achieve cardiac MRI (primary endpoint):
- known and crippling claustrophobia,
- metal clips intracranial, intraocular,
Show all 22Show fewer
- presence of an implantable defibrillator
- presence of a pacemaker
- history of injury by firearm or shrapnel balance without known projections
- hypersensitivity to gadolinium products (or history of systemic sclerosis skin) or severe renal impairment with creatinine clearance <30 ml / min
- any other known cause of contra-indication.
- Mild infarction (rate of late enhancement MRI in less than or equal to 4 segments of 17 during the first MRI)
- Patient previously treated with CPAP prior MI or already experienced with sleep apnea syndrome.
- SAS whose central part is predominantly (> 50%)
- General
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- No affiliation to a French social security recipient or not such a scheme
- Major protected by law (guardianship, curators or under judicial protection)
- deprivation of liberty by judicial or administrative decision
- Increased likelihood of non compliance to the protocol or abandonment under study
- History or presence of psychoactive substance abuse
- pregnancy, become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295
About this study
Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. The entanglement of the two pathologies is actually quite well known, in particular the consequences of one over the other just beginning to be studied. Understanding the pathophysiology through new imaging modalities should improve the management of patients to propose new approaches.
"SAS-IDM" is an interventional and prospective study conducted at the University Hospital of Montpellier. Patients will be divided in three groups depending of the results of the polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the group "severe OSA".
- Conditions
- Recent Acute Myocardial Infarction
- Being tested
- Without Obstructive Sleep Apnea (syndrome), Mild or moderate Obstructive Sleep Apnea (syndrome), Severe Obstructive Sleep Apnea (syndrome), CPAP
- Keywords
- Recent acute myocardial infarction, Obstructive sleep apnée (syndrome), Ventricular remodeling, Continuous Positive Airway Pressure
- Medical subject headings
- Syndrome, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without Obstructive Sleep Apnea (syndrome)Other
Mild or moderate Obstructive Sleep Apnea (syndrome)Other
Severe Obstructive Sleep Apnea (syndrome)Other
CPAPDevice
| Study group | Role | What they receive |
|---|---|---|
| Without Obstructive Sleep Apnea (syndrome) | Other | Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups Receives: Other: Without Obstructive Sleep Apnea (syndrome) |
| Mild or moderate Obstructive Sleep Apnea (syndrome) | Other | Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups Receives: Other: Mild or moderate Obstructive Sleep Apnea (syndrome) |
| Severe Obstructive Sleep Apnea (syndrome) | Other | Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups Receives: Other: Severe Obstructive Sleep Apnea (syndrome); Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diameter (mm) and end diastolic and systolic LV volumes (mL) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Measured: 6 months of acute MI
Transmural enhancement (%) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Measured: 6 months of acute MI
Thickness of the LV wall (mm) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Measured: 6 months of acute MI
Presence no reflow at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Measured: 6 months of acute MI
Secondary outcomes (4)
The difference in cardiac remodeling in cardiac MRI at 6 months between the three diagnostic categories
Measured: At 6 months after inclusion
The difference in cardiac remodeling in cardiac MRI between the date of inclusion and 6 months between diagnostic categories.
Measured: Between the date of inclusion and 6 months
The difference of left ventricular remodeling in cardiac MRI between the date of inclusion and 6 months in the severe OSA group based on the assumption (good compliance and effectiveness of PPC or not)
Measured: Between the date of inclusion and 6 months
The occurrence of cardiovascular events during the first year following the IDM depending on the initial AHI index.
Measured: Between the date of inclusion and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start13 May 2015
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recent Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439294
- Sponsor's protocol ID
- 9541
- Acronym
- SAS-IDM
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2015
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02439294
- Acronym / sponsor ID
- SAS-IDM / 9541
- Conditions
- Recent Acute Myocardial Infarction
- Keywords
- Recent acute myocardial infarction, Obstructive sleep apnée (syndrome), Ventricular remodeling, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 May 2015 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 8 May 2015 (estimated)
- 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.
Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. The entanglement of the two pathologies is actually quite well known, in particular the consequences of one over the other just beginning to be studied. Understanding the pathophysiology through new imaging modalities should improve the management of patients to propose new approaches.
"SAS-IDM" is an interventional and prospective study conducted at the University Hospital of Montpellier. Patients will be divided in three groups depending of the results of the polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the group "severe OSA".
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Without Obstructive Sleep Apnea (syndrome) | Other | Other: Without Obstructive Sleep Apnea (syndrome)Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups |
| Mild or moderate Obstructive Sleep Apnea (syndrome) | Other | Other: Mild or moderate Obstructive Sleep Apnea (syndrome)Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups |
| Severe Obstructive Sleep Apnea (syndrome) | Other | Other: Severe Obstructive Sleep Apnea (syndrome), Device: CPAPSubjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent prior to any study specific procedures,
- Adults, men and women aged < 90 years,
- Hospitalized in Intensive Care Units, MI confirmed by the study of the coronary arteries (coronary angiography) in acute phase (primary coronary angiography) or secondarily (ambulatory IDM IDM initially reperfused by thrombolysis),
- Myocardial infarction defined the criteria normally applied (STEMI: ST segment depression greater than 2 mm in at least 2 contiguous leads or new onset of pain and a left bundle branch block),
- The score of delayed enhancement MRI should be greater than 5 segments of 17 during the first MRI (criterion of severity of AMI),
Key exclusion criteria (22 listed)
- Patients for whom CPAP equipment has demonstrated its usefulness regardless of cardiovascular context
- Contraindication to achieve cardiac MRI (primary endpoint):
- Mild infarction (rate of late enhancement MRI in less than or equal to 4 segments of 17 during the first MRI)
- Patient previously treated with CPAP prior MI or already experienced with sleep apnea syndrome.
- SAS whose central part is predominantly (> 50%)
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 |
|---|---|---|
| Without Obstructive Sleep Apnea (syndrome) | Other | Without Obstructive Sleep Apnea (syndrome) |
| Mild or moderate Obstructive Sleep Apnea (syndrome) | Other | Mild or moderate Obstructive Sleep Apnea (syndrome) |
| Severe Obstructive Sleep Apnea (syndrome) | Other | Severe Obstructive Sleep Apnea (syndrome) |
| CPAP | Device | Severe Obstructive Sleep Apnea (syndrome) |
Primary outcome
Changes in diameter (mm) and end diastolic and systolic LV volumes (mL) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time frame: 6 months of acute MI
Transmural enhancement (%) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time frame: 6 months of acute MI
Thickness of the LV wall (mm) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time frame: 6 months of acute MI
Presence no reflow at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time frame: 6 months of acute MI
4 secondary outcomes
The difference in cardiac remodeling in cardiac MRI at 6 months between the three diagnostic categories
Time frame: At 6 months after inclusion
The difference in cardiac remodeling in cardiac MRI between the date of inclusion and 6 months between diagnostic categories.
Time frame: Between the date of inclusion and 6 months
The difference of left ventricular remodeling in cardiac MRI between the date of inclusion and 6 months in the severe OSA group based on the assumption (good compliance and effectiveness of PPC or not)
Time frame: Between the date of inclusion and 6 months
The occurrence of cardiovascular events during the first year following the IDM depending on the initial AHI index.
Time frame: Between the date of inclusion and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without Obstructive Sleep Apnea (syndrome), Mild or moderate Obstructive Sleep Apnea (syndrome) and Severe Obstructive Sleep Apnea (syndrome) in people with Recent Acute Myocardial Infarction, run by University Hospital, Montpellier 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 6 inclusion and 22 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: finished, as of the sponsor's last update on 13 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in diameter (mm) and end diastolic and systolic LV volumes (mL) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h) (time frame: 6 months of acute MI). 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 13 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.