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

Beijing Anzhen Hospital2 sites in 1 country120 target enrollmentMarch 26, 2018

ConditionsObstructive Sleep Apnea ST Elevation Myocardial Infarction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: Beijing Anzhen Hospital
Enrollment: 120
Locations: 2
Primary Endpoint: Myocardial salvage index
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 26, 2018

End Date

June 30, 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Anzhen Hospital

Responsible Party

Principal Investigator

Shao-Ping Nie

Director, Emergency & Critical Care Center, Professor of Medicine

Beijing Anzhen Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)
•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)

Outcomes

Primary Outcomes

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)