Obstructive Sleep ApneaNCT03444857
CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea and ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 2 sites in China.
Trial summary
The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, ST Elevation Myocardial Infarction
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 26 Mar 2018to 30 Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- First-time STEMI
- Successful PPCI (≥1 coronary artery) within 24h after symptom onset
- Moderate to severe OSA (AHI≥15)
- Written informed consent
Who cannot join
- Prior myocardial infarction
- Prior myocardial revascularization (PCI or CABG)
- Cardiogenic shock (mean arterial pressure <60mmHg), severe heart failure (Killip≥3)
- LM or multivessel disease indicated for CABG
- History of stroke
- Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep <4h/night)
Show all 15Show fewer
- Severe COPD: FEV1/FVC <70% or FEV1 <50% predicted value (within 4 weeks)
- Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)
- Previous or current use of CPAP
- Severe comorbidities: eg. malignancy (life expectancy <2 years)
- Known or planned pregnancy
- Known contraindication to CMR
- Patients with contraindication to CPAP or who cannot tolerate it
- Participation in other clinical trial in recent 3 months
- Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Hospital
Beijing, Beijing Municipality, 100000
Fu-Sui JI, MD
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
About this study
Official title: Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial
The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).
- Being tested
- Continuous positive airway pressure
- Keywords
- Continuous Positive Airway Pressure, Myocardial Salvage, Obstructive Sleep Apnea, ST Elevation Myocardial Infarction
- Medical subject headings
- Sleep Apnea, Obstructive, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
The optimal continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) settings will be determined during 1-2 nights within 7 days after pPCI.
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI Receives: Device: Continuous positive airway pressure |
| Control | No intervention | Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial salvage index
To investigate the effects of CPAP treatment on myocardial salvage index (MSI, assessed by cardiovascular magnetic resonance imaging, CMR) at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start26 Mar 2018 (estimated)
- Primary completion24 Mar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
- Investigators
- Shao-Ping NIE, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444857
- Sponsor's protocol ID
- 2018006
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03444857
- Acronym / sponsor ID
- 2018006
- Keywords
- Continuous Positive Airway Pressure, Myocardial Salvage, Obstructive Sleep Apnea, ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 26 Mar 2018 (estimated)
- Primary completion
- 24 Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 23 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.
The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous positive airway pressureContinuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI |
| Control | No intervention | –Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 80 years old
- First-time STEMI
- Successful PPCI (≥1 coronary artery) within 24h after symptom onset
- Moderate to severe OSA (AHI≥15)
- Written informed consent
Key exclusion criteria (15 listed)
- Prior myocardial infarction
- Prior myocardial revascularization (PCI or CABG)
- Cardiogenic shock (mean arterial pressure <60mmHg), severe heart failure (Killip≥3)
- LM or multivessel disease indicated for CABG
- History of stroke
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 |
|---|---|---|
| Continuous positive airway pressureAlso: CPAPThe optimal continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) settings will be determined during 1-2 nights within 7 days after pPCI. | Device | CPAP treatment |
Primary outcome
Myocardial salvage index
Time frame: 3 months
To investigate the effects of CPAP treatment on myocardial salvage index (MSI, assessed by cardiovascular magnetic resonance imaging, CMR) at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- 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.
Shao-Ping NIE, MD principal investigator
Beijing Anzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea and ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 2 sites in China.
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 5 inclusion and 15 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Shao-Ping NIE, MD (86 13701186772, spnie@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial salvage index (time frame: 3 months). 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 23 Feb 2018.