OSA-ACS Project: Association of OSA and CPAP Therapy With... | NCT03362385

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

NCT03362385

Sponsor

Beijing Anzhen Hospital

Status

Completed

Last Update Posted

Sep 5, 2021Actual

Enrollment

2,160Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea of Adult
Acute Coronary Syndrome

Interventions

Patients with OSA based on sleep study
Patients without OSA based on sleep study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Jan 2020Actual

Completion Date

Dec 2020Actual

First Submitted Date

Nov 7, 2017

First Submission Date that Met QC Criteria

Nov 29, 2017

First Posted Date

Dec 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2021

Last Update Posted Date

Sep 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shao-Ping Nie, Director, Emergency & Critical Care Center, Professor of Medicine, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSA			Other: Patients with OSA based on sleep study
Non-OSA			Other: Patients without OSA based on sleep study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with OSA based on sleep study	Other	Polysomnography or Polygraphy	OSA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular death		Median 24 months
All-cause mortality		Median 24 months
Hospitalization for unstable angina

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In-hospital patients with ACS and undergoing sleep study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital, Capital Medical University		Beijing		100029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41719768	Derived	Gong W, Chen X, Zhao W, Du J, Zhang Z, Fan J, Wang X, Yan Y, Ai H, Li S, Zhou Y, Nie S. Obstructive sleep apnea increases recurrent cardiovascular event risk in younger but not older patients with acute coronary syndrome: a prospective cohort study. Sleep Med. 2026 Jun;142:108829. doi: 10.1016/j.sleep.2026.108829. Epub 2026 Feb 9.
40776960

ID	Term
D054058	Acute Coronary Syndrome
D020181	Sleep Apnea, Obstructive

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases