CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

NCT ID: NCT03444857

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP treatment

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

Group Type EXPERIMENTAL

Continuous positive airway pressure

Intervention Type DEVICE

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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CPAP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Director, Emergency & Critical Care Center, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shao-Ping NIE, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

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Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Shao-Ping NIE, MD

Role: CONTACT

86 13701186772

Facility Contacts

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Fu-Sui JI, MD

Role: primary

Other Identifiers

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2018006

Identifier Type: -

Identifier Source: org_study_id

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