<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/NCT02233634</url>
  </required_header>
  <id_info>
    <org_study_id>107/14</org_study_id>
    <secondary_id>GUDD 1-14</secondary_id>
    <nct_id>NCT02233634</nct_id>
  </id_info>
  <brief_title>Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease</brief_title>
  <acronym>CADOS-CMR</acronym>
  <official_title>Impact of Breathing Maneuvers and Oxygen Administration on Myocardial Oxygenation in Patients With Coronary Artery Disease Compared With Healthy Controls - Non-invasive Assessment With Oxygenation-sensitive Cardiovascular Magnetic Resonance Imaging (OS-CMR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with an impaired blood supply of the heart routinely receive oxygen in order to&#xD;
      improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent&#xD;
      studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart&#xD;
      was able to show that the administration of oxygen or fast breathing can decrease the blood&#xD;
      supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of&#xD;
      oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the&#xD;
      investigators want to investigate, whether the administration of exogenous oxygen via a mask&#xD;
      alone and in combination with fast breathing leads to a decrease in oxygen supply in regions&#xD;
      with already impaired blood supply by a narrowing of a coronary artery of the heart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Patients with acute myocardial ischemia receive oxygen as a standard measure of care to&#xD;
      maintain or improve the myocardial oxygen supply. In 1975 Neil et al. were able to show that&#xD;
      higher oxygen concentration reduces myocardial blood flow. However, since the oxygen&#xD;
      concentration in the blood was significantly increased it was/is assumed that the higher&#xD;
      oxygen supply outweighs the decrease in perfusion. Oxygenation-Sensitive (OS) Cardiovascular&#xD;
      Magnetic Resonance (CMR) is a newer technology that uses the paramagnetic deoxyhemoglobin in&#xD;
      the blood as an endogenous contrast. An drop in tissue oxygenation (drop in oxyhemoglobin)&#xD;
      results in an increase in deoxyhemoglobin, which results in an drop in SI in OS-images. Vice&#xD;
      versa an increase in tissue oxygenation results in an increase in OS-SI. Therefore, OS-CMR&#xD;
      can assess myocardial tissue oxygenation changes non-invasively, free of contrast and free of&#xD;
      radiation. While other diagnostic modalities only give information on myocardial oxygenation&#xD;
      with surrogate parameters that may indicate ischemia OS-CMR gives local functional&#xD;
      information of the myocardial oxygen supply. Studies have been performed using OS-CMR for the&#xD;
      detection of coronary artery disease. More recently breathing maneuvers that change systemic&#xD;
      blood gases have been suggested as a vasoactive stimulus to detect coronary artery disease&#xD;
      and measure changes to the myocardial oxygen supply. Guensch et al. were able to show that&#xD;
      hypercapnia and the combination of hypercapnia and hypoxia lead to a increase of myocardial&#xD;
      oxygenation that can only be explained by an increase blood flow. However, hypocapnia&#xD;
      resulted in a decrease in myocardial oxygenation in healthy volunteers. In a porcine model&#xD;
      the investigators were able to show that the increase in systemic oxygen supply resulted in a&#xD;
      decrease in myocardial blood flow in healthy and swine with an acute coronary artery&#xD;
      stenosis, but a decrease in myocardial oxygenation was only observed in the animals with a&#xD;
      coronary artery stenosis (Abstract Guensch et al: Administration of exogenous oxygen may&#xD;
      worsen myocardial ischemia, ESC 2014, accepted). The impact of hyperoxia as well as&#xD;
      hypocapnia and hypercapnia in humans with a chronic coronary artery disease is poorly&#xD;
      investigated. As the administration of oxygen is part of the treating guidelines in acute&#xD;
      myocardial ischemia and in certain situations (e.g. anesthesia) higher oxygen concentrations&#xD;
      are maintained for safety reasons, it is important to further investigate the role of higher&#xD;
      oxygen concentrations in coronary artery disease. Further the investigators want to shed&#xD;
      light on transient states of hypocapnia and hypercapnia induced by voluntary breathing.&#xD;
      Because OS-CMR is a safe diagnostic tool (no radiation, no contrast, no pharmacologic&#xD;
      vasodilator required) and can give insight on the oxygenation changes of the heart is it&#xD;
      ideal to test the hypothesis. Therefore the investigators want to invite patients with a&#xD;
      known coronary stenosis (confirmed by previous coronary angiography) scheduled for a&#xD;
      percutaneous coronary intervention (staged PCI) or coronary artery bypass surgery to&#xD;
      participate in this study prior to the intervention and compare the MRI results to healthy&#xD;
      volunteers. All participants will perform hyperventilation with a consecutive breath-hold as&#xD;
      well as inhale oxygen for 3-5 minutes while the breathing maneuver is being repeated. For the&#xD;
      patients the results will then be compared to the findings of coronary angiography (QCA,&#xD;
      reduction in lumen-diameter of the vessel).&#xD;
&#xD;
      Objective&#xD;
&#xD;
      With this study the investigators want to investigate whether the administration of oxygen,&#xD;
      as well as performing breathing maneuvers (hyperventilation, breath-holding) have a negative&#xD;
      or positive effect on the oxygenation of myocardium subtended to arteries diseased of&#xD;
      coronary artery disease, as opposed to healthy subjects.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      CAD-patients with a known coronary pathology that are scheduled for a PCI or coronary bypass&#xD;
      surgery will be recruited for the CMR exam prior to the coronary intervention. A i.v. line&#xD;
      will be placed for safety reason. During short breath-holds oxygenation-sensitive baseline&#xD;
      images and cardiac function images will be acquired. The subjects will then be asked to&#xD;
      hyperventilate for one minute with 20-30 breaths/min. Immediately after a maximal breath-hold&#xD;
      will be performed in end-expiration as long as the subject can comfortably bear. During the&#xD;
      entire breath-hold oxygenation sensitive images will be recorded. Whenever the subject feels&#xD;
      the need to breath, he/she can immediately do so and signal the technician with a call bell.&#xD;
      After recovery the subject will breath oxygen 12-15L/min through a mask for 3-5 min after&#xD;
      which oxygenation sensitive images as well as function images will be repeated. The&#xD;
      hyperventilation-breath-hold will be repeated with oxygen. Healthy volunteers will undergo&#xD;
      the same protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration</measure>
    <time_frame>During CMR scan, expected to be on average approx. 45 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of OS-SI changes between healthy and post-stenotic myocardium during the breathing-maneuvers/oxygen administration in CAD patients</measure>
    <time_frame>During CMR scan, expected to be on average approx. 45 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of OS-SI changes between healthy volunteers and and CAD patients during the breathing-maneuvers/oxygen administration</measure>
    <time_frame>During CMR scan, expected to be on average approx. 45 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between OS-SI changes during the breathing maneuvers/oxygen administration and results in quantitative coronary angiography in CAD patients (reduction of lumen diameter)</measure>
    <time_frame>During CMR scan, expected to be on average approx. 45 minutes, and the subsequent coronary angiography</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>CAD Patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers (Control Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Oxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups</description>
    <arm_group_label>CAD Patients</arm_group_label>
    <arm_group_label>Healthy Volunteers (Control Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperventilation Breath-hold (HVBH)</intervention_name>
    <description>1 Minute of Hyperventilation (25/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver</description>
    <arm_group_label>CAD Patients</arm_group_label>
    <arm_group_label>Healthy Volunteers (Control Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HVBH with Oxygen</intervention_name>
    <description>1 Minute of Hyperventilation (25/min) with an oxygen mask mounted (12L/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver</description>
    <arm_group_label>CAD Patients</arm_group_label>
    <arm_group_label>Healthy Volunteers (Control Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with known relevant coronary artery stenosis (defined by previous coronary&#xD;
             angiography, QCA: reduction in lumen-diameter of the vessel &gt;50%) with a scheduled&#xD;
             intervention or operation to treat this stenosis (staged PCI or coronary artery bypass&#xD;
             surgery)&#xD;
&#xD;
          -  CMR feasible prior to intervention or surgery&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  For healthy participants: Absence of cardiovascular and lung disease, and absence of&#xD;
             medication with cardiovascular effects&#xD;
&#xD;
          -  Absence of exclusion criteria&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  General Contraindication against MRI-Scans: (claustrophobia, ferromagnetic implants,&#xD;
             clips, pacemakers, shrapnels, ophthalmic metal deposits)&#xD;
&#xD;
          -  Pregnancy or inconclusive test result&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Consumption of caffeine, tea, treatment of dipyridamol &lt;12h before the scan&#xD;
&#xD;
          -  Medication with calcium antagonists (ok, if can be paused on the day of the scan)&#xD;
&#xD;
          -  Constant medication with nitrates (ok, if can be paused on the day of the scan)&#xD;
&#xD;
          -  Medication with methyl-xanthines&#xD;
&#xD;
          -  Acute myocardial ischemia/myocardial infarction&#xD;
&#xD;
          -  Previous Coronary Bypass Surgery&#xD;
&#xD;
          -  Pulmonary Disease&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
&#xD;
          -  Presence of cardiac or lung disease for healthy volunteers, nicotine consumption&#xD;
             within the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Balthasar Eberle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.jcmr-online.com/content/16/S1/P49</url>
    <description>Explanation and Study Results of a Hyperventilation Breath-Hold in Healthy Volunteers as used in the protocol</description>
  </link>
  <reference>
    <citation>Guensch DP, Fischer K, Flewitt JA, Friedrich MG. Impact of intermittent apnea on myocardial tissue oxygenation--a study using oxygenation-sensitive cardiovascular magnetic resonance. PLoS One. 2013;8(1):e53282. doi: 10.1371/journal.pone.0053282. Epub 2013 Jan 3.</citation>
    <PMID>23301055</PMID>
  </reference>
  <reference>
    <citation>Guensch DP, Fischer K, Flewitt JA, Yu J, Lukic R, Friedrich JA, Friedrich MG. Breathing manoeuvre-dependent changes in myocardial oxygenation in healthy humans. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):409-14. doi: 10.1093/ehjci/jet171. Epub 2013 Sep 27.</citation>
    <PMID>24078154</PMID>
  </reference>
  <reference>
    <citation>Guensch DP, Fischer K, Flewitt JA, Friedrich MG. Myocardial oxygenation is maintained during hypoxia when combined with apnea - a cardiovascular MR study. Physiol Rep. 2013 Oct;1(5):e00098. doi: 10.1002/phy2.98. Epub 2013 Oct 11.</citation>
    <PMID>24303170</PMID>
  </reference>
  <reference>
    <citation>Luu JM, Friedrich MG, Harker J, Dwyer N, Guensch D, Mikami Y, Faris P, Hare JL. Relationship of vasodilator-induced changes in myocardial oxygenation with the severity of coronary artery stenosis: a study using oxygenation-sensitive cardiovascular magnetic resonance. Eur Heart J Cardiovasc Imaging. 2014 Dec;15(12):1358-67. doi: 10.1093/ehjci/jeu138. Epub 2014 Aug 7.</citation>
    <PMID>25104812</PMID>
  </reference>
  <reference>
    <citation>Neill WA, Hattenhauer M. Impairment of myocardial O2 supply due to hyperventilation. Circulation. 1975 Nov;52(5):854-8. doi: 10.1161/01.cir.52.5.854.</citation>
    <PMID>1175266</PMID>
  </reference>
  <reference>
    <citation>Momen A, Mascarenhas V, Gahremanpour A, Gao Z, Moradkhan R, Kunselman A, Boehmer JP, Sinoway LI, Leuenberger UA. Coronary blood flow responses to physiological stress in humans. Am J Physiol Heart Circ Physiol. 2009 Mar;296(3):H854-61. doi: 10.1152/ajpheart.01075.2007. Epub 2009 Jan 23.</citation>
    <PMID>19168724</PMID>
  </reference>
  <reference>
    <citation>Nakao K, Ohgushi M, Yoshimura M, Morooka K, Okumura K, Ogawa H, Kugiyama K, Oike Y, Fujimoto K, Yasue H. Hyperventilation as a specific test for diagnosis of coronary artery spasm. Am J Cardiol. 1997 Sep 1;80(5):545-9. doi: 10.1016/s0002-9149(97)00419-0.</citation>
    <PMID>9294979</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Angiography</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Hyperoxia</keyword>
  <keyword>Carbon Dioxide</keyword>
  <keyword>Apnea</keyword>
  <keyword>Hyperventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02233634
org study id: 107/14
secondary id: GUDD 1-14
nct id: NCT02233634
lead sponsor: 
has dmc: No
Patients with an impaired blood supply of the heart routinely receive oxygen in order to
      improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent
      studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart
      was able to show that the administration of oxygen or fast breathing can decrease the blood
      supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of
      oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the
      investigators want to investigate, whether the administration of exogenous oxygen via a mask
      alone and in combination with fast breathing leads to a decrease in oxygen supply in regions
      with already impaired blood supply by a narrowing of a coronary artery of the heart.
Background

      Patients with acute myocardial ischemia receive oxygen as a standard measure of care to
      maintain or improve the myocardial oxygen supply. In 1975 Neil et al. were able to show that
      higher oxygen concentration reduces myocardial blood flow. However, since the oxygen
      concentration in the blood was significantly increased it was/is assumed that the higher
      oxygen supply outweighs the decrease in perfusion. Oxygenation-Sensitive (OS) Cardiovascular
      Magnetic Resonance (CMR) is a newer technology that uses the paramagnetic deoxyhemoglobin in
      the blood as an endogenous contrast. An drop in tissue oxygenation (drop in oxyhemoglobin)
      results in an increase in deoxyhemoglobin, which results in an drop in SI in OS-images. Vice
      versa an increase in tissue oxygenation results in an increase in OS-SI. Therefore, OS-CMR
      can assess myocardial tissue oxygenation changes non-invasively, free of contrast and free of
      radiation. While other diagnostic modalities only give information on myocardial oxygenation
      with surrogate parameters that may indicate ischemia OS-CMR gives local functional
      information of the myocardial oxygen supply. Studies have been performed using OS-CMR for the
      detection of coronary artery disease. More recently breathing maneuvers that change systemic
      blood gases have been suggested as a vasoactive stimulus to detect coronary artery disease
      and measure changes to the myocardial oxygen supply. Guensch et al. were able to show that
      hypercapnia and the combination of hypercapnia and hypoxia lead to a increase of myocardial
      oxygenation that can only be explained by an increase blood flow. However, hypocapnia
      resulted in a decrease in myocardial oxygenation in healthy volunteers. In a porcine model
      the investigators were able to show that the increase in systemic oxygen supply resulted in a
      decrease in myocardial blood flow in healthy and swine with an acute coronary artery
      stenosis, but a decrease in myocardial oxygenation was only observed in the animals with a
      coronary artery stenosis (Abstract Guensch et al: Administration of exogenous oxygen may
      worsen myocardial ischemia, ESC 2014, accepted). The impact of hyperoxia as well as
      hypocapnia and hypercapnia in humans with a chronic coronary artery disease is poorly
      investigated. As the administration of oxygen is part of the treating guidelines in acute
      myocardial ischemia and in certain situations (e.g. anesthesia) higher oxygen concentrations
      are maintained for safety reasons, it is important to further investigate the role of higher
      oxygen concentrations in coronary artery disease. Further the investigators want to shed
      light on transient states of hypocapnia and hypercapnia induced by voluntary breathing.
      Because OS-CMR is a safe diagnostic tool (no radiation, no contrast, no pharmacologic
      vasodilator required) and can give insight on the oxygenation changes of the heart is it
      ideal to test the hypothesis. Therefore the investigators want to invite patients with a
      known coronary stenosis (confirmed by previous coronary angiography) scheduled for a
      percutaneous coronary intervention (staged PCI) or coronary artery bypass surgery to
      participate in this study prior to the intervention and compare the MRI results to healthy
      volunteers. All participants will perform hyperventilation with a consecutive breath-hold as
      well as inhale oxygen for 3-5 minutes while the breathing maneuver is being repeated. For the
      patients the results will then be compared to the findings of coronary angiography (QCA,
      reduction in lumen-diameter of the vessel).

      Objective

      With this study the investigators want to investigate whether the administration of oxygen,
      as well as performing breathing maneuvers (hyperventilation, breath-holding) have a negative
      or positive effect on the oxygenation of myocardium subtended to arteries diseased of
      coronary artery disease, as opposed to healthy subjects.

      Methods

      CAD-patients with a known coronary pathology that are scheduled for a PCI or coronary bypass
      surgery will be recruited for the CMR exam prior to the coronary intervention. A i.v. line
      will be placed for safety reason. During short breath-holds oxygenation-sensitive baseline
      images and cardiac function images will be acquired. The subjects will then be asked to
      hyperventilate for one minute with 20-30 breaths/min. Immediately after a maximal breath-hold
      will be performed in end-expiration as long as the subject can comfortably bear. During the
      entire breath-hold oxygenation sensitive images will be recorded. Whenever the subject feels
      the need to breath, he/she can immediately do so and signal the technician with a call bell.
      After recovery the subject will breath oxygen 12-15L/min through a mask for 3-5 min after
      which oxygenation sensitive images as well as function images will be repeated. The
      hyperventilation-breath-hold will be repeated with oxygen. Healthy volunteers will undergo
      the same protocol.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration
time frame: During CMR scan, expected to be on average approx. 45 minutes
measure: Comparison of OS-SI changes between healthy and post-stenotic myocardium during the breathing-maneuvers/oxygen administration in CAD patients
time frame: During CMR scan, expected to be on average approx. 45 minutes
measure: Comparison of OS-SI changes between healthy volunteers and and CAD patients during the breathing-maneuvers/oxygen administration
time frame: During CMR scan, expected to be on average approx. 45 minutes
measure: Comparison between OS-SI changes during the breathing maneuvers/oxygen administration and results in quantitative coronary angiography in CAD patients (reduction of lumen diameter)
time frame: During CMR scan, expected to be on average approx. 45 minutes, and the subsequent coronary angiography
arm group label: CAD Patients
arm group type: Active Comparator
description: Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds
arm group label: Healthy Volunteers (Control Group)
arm group type: Active Comparator
description: Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds
intervention type: Drug
intervention name: Oxygen
description: Oxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups
arm group label: CAD Patients
arm group label: Healthy Volunteers (Control Group)
intervention type: Other
intervention name: Hyperventilation Breath-hold (HVBH)
description: 1 Minute of Hyperventilation (25/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver
arm group label: CAD Patients
arm group label: Healthy Volunteers (Control Group)
intervention type: Other
intervention name: HVBH with Oxygen
description: 1 Minute of Hyperventilation (25/min) with an oxygen mask mounted (12L/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver
arm group label: CAD Patients
arm group label: Healthy Volunteers (Control Group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Balthasar Eberle, MD
role: Principal Investigator
affiliation: Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern
facility: 
country: Switzerland
url: http://www.jcmr-online.com/content/16/S1/P49
description: Explanation and Study Results of a Hyperventilation Breath-Hold in Healthy Volunteers as used in the protocol
citation: Guensch DP, Fischer K, Flewitt JA, Friedrich MG. Impact of intermittent apnea on myocardial tissue oxygenation--a study using oxygenation-sensitive cardiovascular magnetic resonance. PLoS One. 2013;8(1):e53282. doi: 10.1371/journal.pone.0053282. Epub 2013 Jan 3.
PMID: 23301055
citation: Guensch DP, Fischer K, Flewitt JA, Yu J, Lukic R, Friedrich JA, Friedrich MG. Breathing manoeuvre-dependent changes in myocardial oxygenation in healthy humans. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):409-14. doi: 10.1093/ehjci/jet171. Epub 2013 Sep 27.
PMID: 24078154
citation: Guensch DP, Fischer K, Flewitt JA, Friedrich MG. Myocardial oxygenation is maintained during hypoxia when combined with apnea - a cardiovascular MR study. Physiol Rep. 2013 Oct;1(5):e00098. doi: 10.1002/phy2.98. Epub 2013 Oct 11.
PMID: 24303170
citation: Luu JM, Friedrich MG, Harker J, Dwyer N, Guensch D, Mikami Y, Faris P, Hare JL. Relationship of vasodilator-induced changes in myocardial oxygenation with the severity of coronary artery stenosis: a study using oxygenation-sensitive cardiovascular magnetic resonance. Eur Heart J Cardiovasc Imaging. 2014 Dec;15(12):1358-67. doi: 10.1093/ehjci/jeu138. Epub 2014 Aug 7.
PMID: 25104812
citation: Neill WA, Hattenhauer M. Impairment of myocardial O2 supply due to hyperventilation. Circulation. 1975 Nov;52(5):854-8. doi: 10.1161/01.cir.52.5.854.
PMID: 1175266
citation: Momen A, Mascarenhas V, Gahremanpour A, Gao Z, Moradkhan R, Kunselman A, Boehmer JP, Sinoway LI, Leuenberger UA. Coronary blood flow responses to physiological stress in humans. Am J Physiol Heart Circ Physiol. 2009 Mar;296(3):H854-61. doi: 10.1152/ajpheart.01075.2007. Epub 2009 Jan 23.
PMID: 19168724
citation: Nakao K, Ohgushi M, Yoshimura M, Morooka K, Okumura K, Ogawa H, Kugiyama K, Oike Y, Fujimoto K, Yasue H. Hyperventilation as a specific test for diagnosis of coronary artery spasm. Am J Cardiol. 1997 Sep 1;80(5):545-9. doi: 10.1016/s0002-9149(97)00419-0.
PMID: 9294979
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease