NCT03444857

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 20, 2018

Last Update Submit

February 22, 2018

Conditions

Obstructive Sleep ApneaST Elevation Myocardial Infarction

Keywords

Continuous Positive Airway PressureMyocardial SalvageObstructive Sleep ApneaST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CPAP treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Continuous positive airway pressureDEVICE

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.

Also known as: CPAP
CPAP treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveST Elevation Myocardial Infarction

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Shao-Ping NIE, MD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Ping NIE, MD

CONTACT

86 13701186772spnie@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Emergency & Critical Care Center, Professor of Medicine

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 23, 2018

Study Start

March 26, 2018

Primary Completion

March 24, 2019

Study Completion

June 30, 2019

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

CN(2)