OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients

September 2, 2021 updated by: Shao-Ping Nie, Beijing Anzhen Hospital

Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project

Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal.

Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated.

Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2160

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-hospital patients with ACS and undergoing sleep study

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Admission with an ACS (including STEMI, NSTEMI, and unstable angina)
  3. Written informed consent

Exclusion Criteria:

  1. Cardiogenic shock (systolic blood pressure <90mmHg)
  2. Cardiac arrest on admission or during hospitalization
  3. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration <4h/night)
  4. Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h)
  5. Previous or current use of CPAP
  6. Known or planned pregnancy
  7. Severe comorbidities: eg. malignancy (life expectancy <2 years)
  8. Patients who cannot tolerate the sleep study or refuse it

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSA
Other: Patients with OSA based on sleep study
Polysomnography or Polygraphy
Non-OSA
Other: Patients without OSA based on sleep study
Polysomnography or Polygraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCEs)
Time Frame: Median 24 months
Including cardiovascular death, myocardial infarction, stroke, ischemia-driven revascularization, and hospitalization for unstable angina or heart failure
Median 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: Median 24 months
Median 24 months
All-cause mortality
Time Frame: Median 24 months
Median 24 months
Hospitalization for unstable angina
Time Frame: Median 24 months
Median 24 months
Ischemia-driven revascularization
Time Frame: Median 24 months
Median 24 months
Any repeat revascularization
Time Frame: Median 24 months
Median 24 months
Myocardial salvage index (assessed by CMR)
Time Frame: 3 months
3 months
Relative proliferation volume within stent segment (% of stent volume)
Time Frame: 12 months
12 months
MACCEs
Time Frame: Median 24 months
Effect of continuous positive airway pressure (CPAP) treatment on MACCEs in patients with OSA and ACS
Median 24 months

Collaborators and Investigators

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

Sponsor

Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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