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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Obstructive Sleep Apnea of Adult; Acute Coronary Syndrome	Other: Patients with OSA based on sleep study; Other: Patients without OSA based on sleep study

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	2000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Impact of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Therapy on Outcomes in Patients With Acute Coronary Syndrome: The OSA-ACS Project
Actual Study Start Date :	May 2015
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	January 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

In-hospital patients with ACS and undergoing sleep study

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Xiao Wang, MD	86-10-84005255	spaceeye123@126.com

Locations

China
Beijing Anzhen Hospital, Capital Medical University	Recruiting
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Principal Investigator: Shao-Ping Nie, MD, PhD

Sponsors and Collaborators

Beijing Anzhen Hospital

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shao-Ping Nie, Director, Emergency & Critical Care Center, Professor of Medicine, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:	NCT03362385 History of Changes
Other Study ID Numbers:	2013025
First Posted:	December 5, 2017
Last Update Posted:	December 5, 2017
Last Verified:	November 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Shao-Ping Nie, Beijing Anzhen Hospital:

Obstructive sleep apnea; Acute coronary syndrome; Continuous positive airway pressure; Outcome

Additional relevant MeSH terms:

Syndrome; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Acute Coronary Syndrome; Disease; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory	Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases