CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03444857
• Other study ID #: 2018006
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2018
• Last updated: February 22, 2018
• Start date: March 26, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2018
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping NIE, MD
• Phone: 86 13701186772
• Email: spnie[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2019
• Est. primary completion date: March 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Infarction
• Myocardial Infarction
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• ST Elevation Myocardial Infarction

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial salvage index	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)	3 months