CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
ApneaLink Type III portable sleep studyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03793582
NCT03793582N/ACompleted

Impact of Obstructive Sleep Apnea on Outcomes in Acute Coronary Syndrome

MetroHealth Medical Center·observational·Posted Jan 4, 2019·Updated Dec 14, 2020

In Brief

An observational study evaluating ApneaLink Type III portable sleep study for OSA and 2 related conditions. Completed, enrolled 128 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2019
Enrollment StartAug 29, 2017
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.5 years ago

Interventions

ApneaLink Type III portable sleep studyother

Type III portable sleep study