<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793582</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-00812</org_study_id>
    <nct_id>NCT03793582</nct_id>
  </id_info>
  <brief_title>Impact of OSA on Outcomes in Acute Coronary Syndrome</brief_title>
  <acronym>ISAACS</acronym>
  <official_title>Impact of Obstructive Sleep Apnea on Outcomes in Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MetroHealth Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes in acute&#xD;
      coronary syndrome (ACS) is crucial in risk assessments and therapeutic recommendations for&#xD;
      affected individuals. Although large epidemiological studies have reported an association&#xD;
      between OSA and both coronary heart disease (CHD) and heart failure (HF), its effect on&#xD;
      outcomes in ACS is still unclear. In contrast to previous theories attributing causation to&#xD;
      OSA, recent studies have hypothesized a cardio protective role of OSA. Repetitive hypoxemic&#xD;
      episodes noted in OSA may lead to myocardial ischemic preconditioning, possibly by increasing&#xD;
      coronary collateral vessel recruitment, conferring protection from acute coronary events. We&#xD;
      propose a prospective, observational, single center study in patients presenting with ACS,&#xD;
      including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) and unstable angina&#xD;
      who undergo coronary revascularization to determine the impact of OSA on clinical outcomes&#xD;
      after ACS. Adult patients above age 18 years who present with myocardial infarction are&#xD;
      eligible. Recruited patients will undergo an overnight sleep study using a level III portable&#xD;
      diagnostic device before hospital discharge. The sleep tracings will be analyzed and audited&#xD;
      by a certified sleep physician. The patients will be divided into 2 groups based on&#xD;
      apnea-hypopnea index (AHI): OSA (AHI ≥ 15) and non-OSA (AHI &lt; 15) groups. The primary end&#xD;
      points of this study were in-hospital, 30 day and 6 month major adverse cardiovascular events&#xD;
      (MACE), defined as a composite endpoint of cardiovascular death, non-fatal MI, stroke and the&#xD;
      need for unplanned repeat revascularization. Secondary endpoints include individual MACE&#xD;
      outcomes of cardiovascular death, non-fatal MI, stroke, need for unplanned repeat&#xD;
      revascularization, heart failure requiring hospitalization, and all-cause mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is very common in middle aged adults. Using a polysomnography&#xD;
      (PSG) derived definition, defined as an apnea hypopnea index (AHI) of &gt;5, it occurs in 20-30&#xD;
      % of males and 10-15 % of females in North America. Various large epidemiological studies&#xD;
      have established a close relationship between OSA and cardiovascular disease including&#xD;
      coronary heart disease (CHD), heart failure, atrial fibrillation, and stroke. Potential&#xD;
      mechanisms including endothelial dysfunction/ systemic inflammation, sympathetic activation,&#xD;
      metabolic dysregulation, and mechanical load effects during respiratory events have been&#xD;
      implicated for this relationship. However, in contrast to previous literature, more recent&#xD;
      studies have also explored a cardio protective role of OSA. Repetitive hypoxemic episodes&#xD;
      noted in OSA may lead to myocardial ischemic preconditioning, conferring protection in the&#xD;
      form of a smaller myocardial infarct size, lower rates of cardiac arrhythmias, heart failure,&#xD;
      and thereby, cardiovascular mortality. Animals exposed to intermittent hypoxia prior to&#xD;
      ischemic insult experience significantly reduced infarct sizes when compared to animals not&#xD;
      exposed to intermittent hypoxemia. Whether a similar effect exists in humans is still&#xD;
      unclear. Recent research indicates better coronary collateral flow in OSA compared to control&#xD;
      subjects presenting with acute coronary syndrome (ACS), which potentially could explain a&#xD;
      cardioprotective role. Others have reported variable outcomes of coronary plaque burden and&#xD;
      lesion complexity, restenosis and target vessel revascularization, serological markers such&#xD;
      as troponin T, high sensitivity-C reactive protein (hs-CRP) and N-terminal pro brain&#xD;
      natriuretic peptide (NT-proBNP), and major adverse cardiovascular events (MACE) in OSA vs.&#xD;
      control subjects. Further, some of these early reports were limited by available devices,&#xD;
      technology and methodology of the era. The objective of this study is to examine the&#xD;
      prognostic role of OSA in patients with acute coronary syndrome (ACS). We tested the&#xD;
      hypothesis whether OSA predicts subsequent MACE in patients undergoing percutaneous coronary&#xD;
      intervention.&#xD;
&#xD;
      Methods This is a prospective, single center, observational study of patients presenting with&#xD;
      ACS, including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) and unstable&#xD;
      angina who undergo coronary revascularization at our tertiary care center. A total of 160&#xD;
      adult patients above age 18 years who meet our inclusion/ exclusion criteria will be&#xD;
      enrolled. The estimated duration for this study is 2017-2018.&#xD;
&#xD;
      Prospective eligible patients who present for treatment for ACS at our institution in the&#xD;
      study period will be approached for recruitment. Exclusion criteria for the study include:&#xD;
      pregnancy, post-cardiac arrest patients, diagnosis of medical conditions associated with&#xD;
      predicted survival of &lt; 6 months, need for tracheostomy and prolonged mechanical ventilation,&#xD;
      prior treatment for sleep disordered breathing and unavailable sleep data (due to death, no&#xD;
      informed consent, uncooperative subject, technical difficulties, miscellaneous).&#xD;
&#xD;
      All subjects or their legally authorized representatives must provide written informed&#xD;
      consent before any study-related procedure can be conducted. All recruited patients will&#xD;
      undergo a level III sleep study within 48 to 72 hours prior to discharge. The patients will&#xD;
      then be separated into OSA (AHI≥15 events/ h) and non-OSA (AHI&lt;15) groups based on AHI.&#xD;
&#xD;
      There will be no financial incentive offered to patients. All recruited patients will be&#xD;
      treated according to Declaration of Helsinki and amendments, World Medical Association&#xD;
      Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects&#xD;
      and standard clinical guidelines.&#xD;
&#xD;
      Study data will be collected and managed using REDCap electronic data capture tools hosted at&#xD;
      MetroHealth Medical Center. REDCap (Research Electronic Data Capture) is a secure, web-based&#xD;
      application designed to support data capture for research studies, providing: 1) an intuitive&#xD;
      interface for validated data entry; 2) audit trails for tracking data manipulation and export&#xD;
      procedures; 3) automated export procedures for seamless data downloads to common statistical&#xD;
      packages; and 4) procedures for importing data from external sources.&#xD;
&#xD;
      Study Endpoints Baseline patient information will be collected prospectively at presentation&#xD;
      for the index hospitalization for acute MI including: demographic information, cardiovascular&#xD;
      risk factors, medical conditions, current medications, and relevant laboratory test values.&#xD;
      The primary end point of this study were in-hospital, 30 day major adverse cardiac events&#xD;
      (MACE), defined as a composite endpoint of cardiovascular death, non-fatal MI, stroke and the&#xD;
      need for unplanned repeat revascularization. Secondary endpoints include 6 month major&#xD;
      adverse cardiac events (MACE), individual MACE cardiovascular death, non-fatal MI, stroke,&#xD;
      need for unplanned repeat revascularization, ST segment resolution (STR), heart failure&#xD;
      requiring hospitalization, and all-cause mortality.&#xD;
&#xD;
      Percutaneous Coronary Intervention Primary PCI will be performed according to the standard&#xD;
      clinical practice. There are no restrictions to the usage of pharmacologic and device&#xD;
      strategies during PCI. PCI is defined as any intervention to a major epicardial coronary&#xD;
      artery with a significant stenosis based on ≥70%-diameter narrowing on visual estimation&#xD;
      (≥50% for left main) and/or fulfilling physiological criteria for revascularization (i.e.,&#xD;
      fractional flow reserve ≤0.80, intravascular ultrasound-IVUS). Angiographic findings&#xD;
      including TIMI flow and ST resolution will be obtained as standard of care by the cardiology&#xD;
      team.&#xD;
&#xD;
      Echocardiography Comprehensive Transthoracic 2D and Doppler echocardiography using&#xD;
      commercially available echocardiography machines will be obtained during hospitalization.&#xD;
      Standard parasternal, apical, and subcostal views will be obtained with the subject in a left&#xD;
      lateral recumbent position. Images were stored digitally and on VHS videotape, which were&#xD;
      subsequently analyzed. All measurements will be made according to American Society of&#xD;
      Echocardiography Guidelines.&#xD;
&#xD;
      Overnight Sleep Study All sleep studies will be conducted using a Resmed ApneaLink Air&#xD;
      standardized level III portable diagnostic device (ResMed Corporation, Poway, California).&#xD;
      Although limited by its inability to identify sleep stages and lack of an objective&#xD;
      measurement of sleep duration, this device has been validated for use against in-laboratory&#xD;
      polysomnography with sensitivity and specificity around 91% and 95% at an AHI value of ≥15/&#xD;
      hour, respectively. Outputs recorded from the portable diagnostic device include nasal&#xD;
      airflow (nasal pressure transducer), thoraco-abdominal movements (inductive respiratory&#xD;
      band), arterial oxygen saturation (pulse oximetry), and snoring episodes (derived from the&#xD;
      integrated pressure transducer). All studies will be manually scored and analyzed by a&#xD;
      certified sleep physician. To ensure the accuracy and consistency of scorings, a second sleep&#xD;
      physician will audit the studies.&#xD;
&#xD;
      The primary measure of the sleep study will be the AHI, quantified as the total number of&#xD;
      apneas and hypopneas per hour of sleep. The respiratory event scoring will be performed&#xD;
      according to the American Academy of Sleep Medicine guidelines.&#xD;
&#xD;
      Standardized Obstructive Sleep Apnea Questionnaire Administration During hospitalization for&#xD;
      acute MI, recruited patients will be administered the STOP-BANG Questionnaire, Berlin&#xD;
      Questionnaire (BQ) and Epworth Sleepiness Scale (ESS) by face-to-face interviews by an&#xD;
      investigator.&#xD;
&#xD;
      Referral to Sleep Clinic All patients diagnosed with OSA during this study will be referred&#xD;
      to the Sleep Clinic at MetroHealth Medical Center for further evaluation and treatment.&#xD;
      Relevant sleep study data will be made available to patients and clinicians.&#xD;
&#xD;
      Follow up Patient data will be collected at 30-days and 6 months to record outcomes.&#xD;
&#xD;
      Sample- Size Calculation According to previous study, 23.5% of patients with OSA, based on an&#xD;
      AHI ≥10 are expected to have adverse MACE after undergoing PCI for ACS, whereas only 5.3%&#xD;
      non-OSA patients experienced these events. Based on 85% power and a significance level of 5%,&#xD;
      the required sample size is 130 (OSA, n=65; non-OSA, n=65). Given that an estimated 20% of&#xD;
      the sleep studies may not be successful (due to premature device removal by the patients or&#xD;
      technical errors), a minimum of 162 recruited patients is needed. The projected sample size&#xD;
      of 160 participants will provide sufficient power to test the primary hypothesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients with major adverse cardiac events (MACE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual MACE outcomes</measure>
    <time_frame>30 days and 6 months</time_frame>
    <description>Number of patients with nonfatal MI, CVA, unplanned revascularization, CHF, CV death, all-cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with major adverse cardiac events</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>OSA</condition>
  <condition>ACS - Acute Coronary Syndrome</condition>
  <condition>Major Adverse Cardiac Events</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>All subjects agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ApneaLink Type III portable sleep study</intervention_name>
    <description>Type III portable sleep study</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients admitted to MetroHealth Medical Center with acute coronary syndrome&#xD;
        (ACS) that meet inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients presenting with:&#xD;
&#xD;
          -  Acute coronary syndrome, including:&#xD;
&#xD;
               -  ST segment elevation (STEMI)&#xD;
&#xD;
               -  non-ST segment elevation (NSTEMI)&#xD;
&#xD;
               -  unstable angina&#xD;
&#xD;
          -  Who undergo coronary revascularization at our tertiary care center .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Post-cardiac arrest patients&#xD;
&#xD;
          -  Diagnosis of medical conditions associated with predicted survival of &lt; 6 months&#xD;
&#xD;
          -  Need for tracheostomy and prolonged mechanical ventilation&#xD;
&#xD;
          -  Prior treatment for sleep disordered breathing and unavailable sleep data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Auckley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MetroHealth Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>11208620</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25515104</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17196456</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23738622</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MetroHealth Medical Center</investigator_affiliation>
    <investigator_full_name>Dennis Auckley, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>OSA</keyword>
  <keyword>ACS (Acute Coronary Syndrome)</keyword>
  <keyword>MACE (Major Adverse Cardiac Events)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793582
org study id: IRB16-00812
nct id: NCT03793582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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 (AHI≥15 events/ h) and non-OSA (AHI<15) 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) and/or fulfilling physiological criteria for revascularization (i.e.,
      fractional flow reserve ≤0.80, 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, 23.5% of patients with OSA, based on an
      AHI ≥10 are expected to have adverse MACE after undergoing PCI for ACS, whereas only 5.3%
      non-OSA patients experienced these events. Based on 85% power and a significance level of 5%,
      the required sample size is 130 (OSA, n=65; non-OSA, n=65). 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.
observational model: Cohort
time perspective: Prospective
measure: MACE
time frame: 30 days
description: Number of patients with major adverse cardiac events (MACE)
measure: Individual MACE outcomes
time frame: 30 days and 6 months
description: Number of patients with nonfatal MI, CVA, unplanned revascularization, CHF, CV death, all-cause death
measure: MACE
time frame: 6 months
description: Number of patients with major adverse cardiac events
arm group label: Study group
description: All subjects agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria
intervention type: Diagnostic Test
intervention name: ApneaLink Type III portable sleep study
description: Type III portable sleep study
arm group label: Study group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dennis Auckley, MD
role: Principal Investigator
affiliation: MetroHealth Medical Center
facility: 
country: United States
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: MetroHealth Medical Center
investigator full name: Dennis Auckley, MD
investigator title: Professor of Medicine
mesh term: Acute Coronary Syndrome
mesh term: Cardiovascular Diseases
mesh term: Syndrome
sharing ipd: Undecided
ipd description: Undecided