CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

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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

  • 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)
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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

Trial contacts and locations

2

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Central trial contact

Shao-Ping NIE, MD

Data sourced from clinicaltrials.gov

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