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

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ClinicalTrials.gov Identifier: NCT03362385
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

Study Description
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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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362385


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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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    Key Record Dates
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