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CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

Primary Purpose

Obstructive Sleep Apnea, ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continuous Positive Airway Pressure, Myocardial Salvage, Obstructive Sleep Apnea, ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Hospital
  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP treatment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 20, 2018
Last Updated
February 22, 2018
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03444857
Brief Title
CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2018 (Anticipated)
Primary Completion Date
March 24, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, ST Elevation Myocardial Infarction
Keywords
Continuous Positive Airway Pressure, Myocardial Salvage, Obstructive Sleep Apnea, ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
Continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) plus standard care (according to current STEMI guidelines) for 3 months after pPCI
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myocardial salvage index
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Ping NIE, MD
Phone
86 13701186772
Email
spnie@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Ping NIE, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu-Sui JI, MD
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

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