CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients
NCT ID: NCT03444857
Last Updated: 2018-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-03-26
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPAP treatment
Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI
Continuous positive airway pressure
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.
Control
Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA
No interventions assigned to this group
Interventions
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Continuous positive airway pressure
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. First-time STEMI
3. Successful PPCI (≥1 coronary artery) within 24h after symptom onset
4. Moderate to severe OSA (AHI≥15)
5. Written informed consent
Exclusion Criteria
2. Prior myocardial revascularization (PCI or CABG)
3. Cardiogenic shock (mean arterial pressure \<60mmHg), severe heart failure (Killip≥3)
4. LM or multivessel disease indicated for CABG
5. History of stroke
6. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep \<4h/night)
7. Severe COPD: FEV1/FVC \<70% or FEV1 \<50% predicted value (within 4 weeks)
8. Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)
9. Previous or current use of CPAP
10. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
11. Known or planned pregnancy
12. Known contraindication to CMR
13. Patients with contraindication to CPAP or who cannot tolerate it
14. Participation in other clinical trial in recent 3 months
15. 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
18 Years
80 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Shao-Ping Nie
Director, Emergency & Critical Care Center, Professor of Medicine
Principal Investigators
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Shao-Ping NIE, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Fu-Sui JI, MD
Role: primary
Other Identifiers
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2018006
Identifier Type: -
Identifier Source: org_study_id
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