CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

Capital Medical University

Status: Unknown

Conditions: ST Elevation Myocardial Infarction; Obstructive Sleep Apnea

Treatments: Device: Continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03444857

2018006

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

CPAP treatment

Experimental group

Description:

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

Treatment:

Device: Continuous positive airway pressure

Control

No Intervention group

Description:

Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA