Impact of OSA on Outcomes in Acute Coronary Syndrome

NCT03793582 | Completed FDA Device

• 1 other identifier: IRB16-00812
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes in acute coronary syndrome (ACS) is crucial in risk assessments and therapeutic recommendations for affected individuals. Although large epidemiological studies have reported an association between OSA and both coronary heart disease (CHD) and heart failure (HF), its effect on outcomes in ACS is still unclear. In contrast to previous theories attributing causation to OSA, recent studies have hypothesized a cardio protective role of OSA. Repetitive hypoxemic episodes noted in OSA may lead to myocardial ischemic preconditioning, possibly by increasing coronary collateral vessel recruitment, conferring protection from acute coronary events. We propose a prospective, observational, single center study in patients presenting with ACS, including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) and unstable angina who undergo coronary revascularization to determine the impact of OSA on clinical outcomes after ACS. Adult patients above age 18 years who present with myocardial infarction are eligible. Recruited patients will undergo an overnight sleep study using a level III portable diagnostic device before hospital discharge. The sleep tracings will be analyzed and audited by a certified sleep physician. The patients will be divided into 2 groups based on apnea-hypopnea index (AHI): OSA (AHI ≥ 15) and non-OSA (AHI \< 15) groups. The primary end points of this study were in-hospital, 30 day and 6 month major adverse cardiovascular events (MACE), defined as a composite endpoint of cardiovascular death, non-fatal MI, stroke and the need for unplanned repeat revascularization. Secondary endpoints include individual MACE outcomes of cardiovascular death, non-fatal MI, stroke, need for unplanned repeat revascularization, heart failure requiring hospitalization, and all-cause mortality.

Conditions

OSA; ACS - Acute Coronary Syndrome; Major Adverse Cardiac Events

Keywords

OSA; ACS (Acute Coronary Syndrome); MACE (Major Adverse Cardiac Events)

Outcome Measures

Primary Outcomes (1)

• MACE

  Number of patients with major adverse cardiac events (MACE)

  30 days

Secondary Outcomes (2)

• Individual MACE outcomes

  30 days and 6 months

• MACE

  6 months

Study Arms (1)

Study group

All subjects agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria

Diagnostic Test: ApneaLink Type III portable sleep study

Interventions

ApneaLink Type III portable sleep study DIAGNOSTIC_TEST

Type III portable sleep study

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients admitted to MetroHealth Medical Center with acute coronary syndrome (ACS) that meet inclusion and exclusion criteria.

You may qualify if:

• Patients presenting with:
• Acute coronary syndrome, including:
• ST segment elevation (STEMI)
• non-ST segment elevation (NSTEMI)
• unstable angina
• Who undergo coronary revascularization at our tertiary care center .

You may not qualify if:

• Pregnancy
• Post-cardiac arrest patients
• Diagnosis of medical conditions associated with predicted survival of \< 6 months
• Need for tracheostomy and prolonged mechanical ventilation
• Prior treatment for sleep disordered breathing and unavailable sleep data

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (4)

• Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Nieto FJ, O'Connor GT, Boland LL, Schwartz JE, Samet JM. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med. 2001 Jan;163(1):19-25. doi: 10.1164/ajrccm.163.1.2001008.

  PMID: 11208620 BACKGROUND

• Hla KM, Young T, Hagen EW, Stein JH, Finn LA, Nieto FJ, Peppard PE. Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study. Sleep. 2015 May 1;38(5):677-84. doi: 10.5665/sleep.4654.

  PMID: 25515104 BACKGROUND

• Yumino D, Tsurumi Y, Takagi A, Suzuki K, Kasanuki H. Impact of obstructive sleep apnea on clinical and angiographic outcomes following percutaneous coronary intervention in patients with acute coronary syndrome. Am J Cardiol. 2007 Jan 1;99(1):26-30. doi: 10.1016/j.amjcard.2006.07.055. Epub 2006 Nov 2.

  PMID: 17196456 BACKGROUND

• Hein T, Loo G, Ng WY, Tai BC, Kajiya T, Tan A, Khoo SM, Chan M, Low AF, Chia BL, Richards M, Lee CH. Relationship between apnoea-hypopnoea index and angiographic coronary disease phenotypes in patients presenting with acute myocardial infarction. Acute Card Care. 2013 Jun;15(2):26-33. doi: 10.3109/17482941.2012.741249.

  PMID: 23738622 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Dennis Auckley, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: January 4, 2019
• Study Start: August 29, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

US (1)