Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03793582
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2018-11-21
Brief Title:
Impact of OSA on Outcomes in Acute Coronary Syndrome
Sponsor:
MetroHealth Medical Center
Organization:
MetroHealth Medical Center
Study Overview
Official Title:
Impact of Obstructive Sleep Apnea on Outcomes in Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISAACS
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
Detailed Description:
Obstructive sleep apnea OSA is very common in middle aged adults Using a polysomnography PSG derived definition defined as an apnea hypopnea index AHI of 5 it occurs in 20-30 of males and 10-15 of females in North America Various large epidemiological studies have established a close relationship between OSA and cardiovascular disease including coronary heart disease CHD heart failure atrial fibrillation and stroke Potential mechanisms including endothelial dysfunction systemic inflammation sympathetic activation metabolic dysregulation and mechanical load effects during respiratory events have been implicated for this relationship However in contrast to previous literature more recent studies have also explored a cardio protective role of OSA Repetitive hypoxemic episodes noted in OSA may lead to myocardial ischemic preconditioning conferring protection in the form of a smaller myocardial infarct size lower rates of cardiac arrhythmias heart failure and thereby cardiovascular mortality Animals exposed to intermittent hypoxia prior to ischemic insult experience significantly reduced infarct sizes when compared to animals not exposed to intermittent hypoxemia Whether a similar effect exists in humans is still unclear Recent research indicates better coronary collateral flow in OSA compared to control subjects presenting with acute coronary syndrome ACS which potentially could explain a cardioprotective role Others have reported variable outcomes of coronary plaque burden and lesion complexity restenosis and target vessel revascularization serological markers such as troponin T high sensitivity-C reactive protein hs-CRP and N-terminal pro brain natriuretic peptide NT-proBNP and major adverse cardiovascular events MACE in OSA vs control subjects Further some of these early reports were limited by available devices technology and methodology of the era The objective of this study is to examine the prognostic role of OSA in patients with acute coronary syndrome ACS We tested the hypothesis whether OSA predicts subsequent MACE in patients undergoing percutaneous coronary intervention
Methods This is a prospective single center observational study of patients presenting with ACS including ST segment elevation STEMI non-ST segment elevation NSTEMI and unstable angina who undergo coronary revascularization at our tertiary care center A total of 160 adult patients above age 18 years who meet our inclusion exclusion criteria will be enrolled The estimated duration for this study is 2017-2018
Prospective eligible patients who present for treatment for ACS at our institution in the study period will be approached for recruitment Exclusion criteria for the study include 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 due to death no informed consent uncooperative subject technical difficulties miscellaneous
All subjects or their legally authorized representatives must provide written informed consent before any study-related procedure can be conducted All recruited patients will undergo a level III sleep study within 48 to 72 hours prior to discharge The patients will then be separated into OSA AHI15 events h and non-OSA AHI15 groups based on AHI
There will be no financial incentive offered to patients All recruited patients will be treated according to Declaration of Helsinki and amendments World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects and standard clinical guidelines
Study data will be collected and managed using REDCap electronic data capture tools hosted at MetroHealth Medical Center REDCap Research Electronic Data Capture is a secure web-based application designed to support data capture for research studies providing 1 an intuitive interface for validated data entry 2 audit trails for tracking data manipulation and export procedures 3 automated export procedures for seamless data downloads to common statistical packages and 4 procedures for importing data from external sources
Study Endpoints Baseline patient information will be collected prospectively at presentation for the index hospitalization for acute MI including demographic information cardiovascular risk factors medical conditions current medications and relevant laboratory test values The primary end point of this study were in-hospital 30 day major adverse cardiac events MACE defined as a composite endpoint of cardiovascular death non-fatal MI stroke and the need for unplanned repeat revascularization Secondary endpoints include 6 month major adverse cardiac events MACE individual MACE cardiovascular death non-fatal MI stroke need for unplanned repeat revascularization ST segment resolution STR heart failure requiring hospitalization and all-cause mortality
Percutaneous Coronary Intervention Primary PCI will be performed according to the standard clinical practice There are no restrictions to the usage of pharmacologic and device strategies during PCI PCI is defined as any intervention to a major epicardial coronary artery with a significant stenosis based on 70-diameter narrowing on visual estimation 50 for left main andor fulfilling physiological criteria for revascularization ie fractional flow reserve 080 intravascular ultrasound-IVUS Angiographic findings including TIMI flow and ST resolution will be obtained as standard of care by the cardiology team
Echocardiography Comprehensive Transthoracic 2D and Doppler echocardiography using commercially available echocardiography machines will be obtained during hospitalization Standard parasternal apical and subcostal views will be obtained with the subject in a left lateral recumbent position Images were stored digitally and on VHS videotape which were subsequently analyzed All measurements will be made according to American Society of Echocardiography Guidelines
Overnight Sleep Study All sleep studies will be conducted using a Resmed ApneaLink Air standardized level III portable diagnostic device ResMed Corporation Poway California Although limited by its inability to identify sleep stages and lack of an objective measurement of sleep duration this device has been validated for use against in-laboratory polysomnography with sensitivity and specificity around 91 and 95 at an AHI value of 15 hour respectively Outputs recorded from the portable diagnostic device include nasal airflow nasal pressure transducer thoraco-abdominal movements inductive respiratory band arterial oxygen saturation pulse oximetry and snoring episodes derived from the integrated pressure transducer All studies will be manually scored and analyzed by a certified sleep physician To ensure the accuracy and consistency of scorings a second sleep physician will audit the studies
The primary measure of the sleep study will be the AHI quantified as the total number of apneas and hypopneas per hour of sleep The respiratory event scoring will be performed according to the American Academy of Sleep Medicine guidelines
Standardized Obstructive Sleep Apnea Questionnaire Administration During hospitalization for acute MI recruited patients will be administered the STOP-BANG Questionnaire Berlin Questionnaire BQ and Epworth Sleepiness Scale ESS by face-to-face interviews by an investigator
Referral to Sleep Clinic All patients diagnosed with OSA during this study will be referred to the Sleep Clinic at MetroHealth Medical Center for further evaluation and treatment Relevant sleep study data will be made available to patients and clinicians
Follow up Patient data will be collected at 30-days and 6 months to record outcomes
Sample- Size Calculation According to previous study 235 of patients with OSA based on an AHI 10 are expected to have adverse MACE after undergoing PCI for ACS whereas only 53 non-OSA patients experienced these events Based on 85 power and a significance level of 5 the required sample size is 130 OSA n65 non-OSA n65 Given that an estimated 20 of the sleep studies may not be successful due to premature device removal by the patients or technical errors a minimum of 162 recruited patients is needed The projected sample size of 160 participants will provide sufficient power to test the primary hypothesis
Methods This is a prospective single center observational study of patients presenting with ACS including ST segment elevation STEMI non-ST segment elevation NSTEMI and unstable angina who undergo coronary revascularization at our tertiary care center A total of 160 adult patients above age 18 years who meet our inclusion exclusion criteria will be enrolled The estimated duration for this study is 2017-2018
Prospective eligible patients who present for treatment for ACS at our institution in the study period will be approached for recruitment Exclusion criteria for the study include 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 due to death no informed consent uncooperative subject technical difficulties miscellaneous
All subjects or their legally authorized representatives must provide written informed consent before any study-related procedure can be conducted All recruited patients will undergo a level III sleep study within 48 to 72 hours prior to discharge The patients will then be separated into OSA AHI15 events h and non-OSA AHI15 groups based on AHI
There will be no financial incentive offered to patients All recruited patients will be treated according to Declaration of Helsinki and amendments World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects and standard clinical guidelines
Study data will be collected and managed using REDCap electronic data capture tools hosted at MetroHealth Medical Center REDCap Research Electronic Data Capture is a secure web-based application designed to support data capture for research studies providing 1 an intuitive interface for validated data entry 2 audit trails for tracking data manipulation and export procedures 3 automated export procedures for seamless data downloads to common statistical packages and 4 procedures for importing data from external sources
Study Endpoints Baseline patient information will be collected prospectively at presentation for the index hospitalization for acute MI including demographic information cardiovascular risk factors medical conditions current medications and relevant laboratory test values The primary end point of this study were in-hospital 30 day major adverse cardiac events MACE defined as a composite endpoint of cardiovascular death non-fatal MI stroke and the need for unplanned repeat revascularization Secondary endpoints include 6 month major adverse cardiac events MACE individual MACE cardiovascular death non-fatal MI stroke need for unplanned repeat revascularization ST segment resolution STR heart failure requiring hospitalization and all-cause mortality
Percutaneous Coronary Intervention Primary PCI will be performed according to the standard clinical practice There are no restrictions to the usage of pharmacologic and device strategies during PCI PCI is defined as any intervention to a major epicardial coronary artery with a significant stenosis based on 70-diameter narrowing on visual estimation 50 for left main andor fulfilling physiological criteria for revascularization ie fractional flow reserve 080 intravascular ultrasound-IVUS Angiographic findings including TIMI flow and ST resolution will be obtained as standard of care by the cardiology team
Echocardiography Comprehensive Transthoracic 2D and Doppler echocardiography using commercially available echocardiography machines will be obtained during hospitalization Standard parasternal apical and subcostal views will be obtained with the subject in a left lateral recumbent position Images were stored digitally and on VHS videotape which were subsequently analyzed All measurements will be made according to American Society of Echocardiography Guidelines
Overnight Sleep Study All sleep studies will be conducted using a Resmed ApneaLink Air standardized level III portable diagnostic device ResMed Corporation Poway California Although limited by its inability to identify sleep stages and lack of an objective measurement of sleep duration this device has been validated for use against in-laboratory polysomnography with sensitivity and specificity around 91 and 95 at an AHI value of 15 hour respectively Outputs recorded from the portable diagnostic device include nasal airflow nasal pressure transducer thoraco-abdominal movements inductive respiratory band arterial oxygen saturation pulse oximetry and snoring episodes derived from the integrated pressure transducer All studies will be manually scored and analyzed by a certified sleep physician To ensure the accuracy and consistency of scorings a second sleep physician will audit the studies
The primary measure of the sleep study will be the AHI quantified as the total number of apneas and hypopneas per hour of sleep The respiratory event scoring will be performed according to the American Academy of Sleep Medicine guidelines
Standardized Obstructive Sleep Apnea Questionnaire Administration During hospitalization for acute MI recruited patients will be administered the STOP-BANG Questionnaire Berlin Questionnaire BQ and Epworth Sleepiness Scale ESS by face-to-face interviews by an investigator
Referral to Sleep Clinic All patients diagnosed with OSA during this study will be referred to the Sleep Clinic at MetroHealth Medical Center for further evaluation and treatment Relevant sleep study data will be made available to patients and clinicians
Follow up Patient data will be collected at 30-days and 6 months to record outcomes
Sample- Size Calculation According to previous study 235 of patients with OSA based on an AHI 10 are expected to have adverse MACE after undergoing PCI for ACS whereas only 53 non-OSA patients experienced these events Based on 85 power and a significance level of 5 the required sample size is 130 OSA n65 non-OSA n65 Given that an estimated 20 of the sleep studies may not be successful due to premature device removal by the patients or technical errors a minimum of 162 recruited patients is needed The projected sample size of 160 participants will provide sufficient power to test the primary hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None