CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

Not Applicable

• Conditions: Obstructive Sleep Apnea; ST Elevation Myocardial Infarction
• Interventions: Device: Continuous positive airway pressure

• Registration Number: NCT03444857
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23
• Study Start: 2018-03-26
• Primary Completion: 2019-03-24
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 18 to 80 years old
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

1. Prior myocardial infarction
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP treatment	Continuous positive airway pressure	Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI

Primary Outcome Measures

Name	Time	Method
Myocardial salvage index	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)

Trial Locations

Locations (2)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China