CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients

February 22, 2018 updated by: Shao-Ping Nie, Beijing Anzhen Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shao-Ping NIE, MD
  • Phone Number: 86 13701186772
  • Email: spnie@126.com

Study Locations

  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Hospital
        • Contact:
          • Fu-Sui JI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • CPAP
No Intervention: Control
Standard care (according to current STEMI guidelines) for 3 months after PPCI with no intervention for OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Shao-Ping NIE, MD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 26, 2018

Primary Completion (Anticipated)

March 24, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST Elevation Myocardial Infarction

Clinical Trials on Continuous positive airway pressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe