Coronary Artery DiseaseCADOS-CMRNCT02233634
Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease
A study testing Oxygen, Hyperventilation Breath-hold (HVBH) and HVBH with Oxygen in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Oxygen, Hyperventilation Breath-hold (HVBH) and HVBH with Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2014to 2 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with known relevant coronary artery stenosis (defined by previous coronary angiography, QCA: reduction in lumen-diameter of the vessel >50%) with a scheduled intervention or operation to treat this stenosis (staged PCI or coronary artery bypass surgery)
- CMR feasible prior to intervention or surgery
- Age ≥18 years
- Written informed consent
- For healthy participants: Absence of cardiovascular and lung disease, and absence of medication with cardiovascular effects
- Absence of exclusion criteria
Who cannot join
- General Contraindication against MRI-Scans: (claustrophobia, ferromagnetic implants, clips, pacemakers, shrapnels, ophthalmic metal deposits)
- Pregnancy or inconclusive test result
- Age <18 years
- Inability to give informed consent
- Consumption of caffeine, tea, treatment of dipyridamol <12h before the scan
- Medication with calcium antagonists (ok, if can be paused on the day of the scan)
Show all 13Show fewer
- Constant medication with nitrates (ok, if can be paused on the day of the scan)
- Medication with methyl-xanthines
- Acute myocardial ischemia/myocardial infarction
- Previous Coronary Bypass Surgery
- Pulmonary Disease
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Presence of cardiac or lung disease for healthy volunteers, nicotine consumption within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Oxygen, Hyperventilation Breath-hold (HVBH), HVBH with Oxygen
- Keywords
- Coronary Angiography, Magnetic Resonance Imaging, Oxygen, Hyperoxia, Carbon Dioxide, Apnea, Hyperventilation
- Medical subject headings
- Coronary Artery Disease, Hyperoxia, Apnea, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Oxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups
Hyperventilation Breath-hold (HVBH)Other
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
HVBH with OxygenOther
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
| Study group | Role | What they receive |
|---|---|---|
| CAD Patients | Active comparator | Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds Receives: Drug: Oxygen; Other: Hyperventilation Breath-hold (HVBH); Other: HVBH with Oxygen |
| Healthy Volunteers (Control Group) | Active comparator | Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds Receives: Drug: Oxygen; Other: Hyperventilation Breath-hold (HVBH); Other: HVBH with Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration
Measured: During CMR scan, expected to be on average approx. 45 minutes
Secondary outcomes (3)
Comparison of OS-SI changes between healthy and post-stenotic myocardium during the breathing-maneuvers/oxygen administration in CAD patients
Measured: During CMR scan, expected to be on average approx. 45 minutes
Comparison of OS-SI changes between healthy volunteers and and CAD patients during the breathing-maneuvers/oxygen administration
Measured: During CMR scan, expected to be on average approx. 45 minutes
Comparison between OS-SI changes during the breathing maneuvers/oxygen administration and results in quantitative coronary angiography in CAD patients (reduction of lumen diameter)
Measured: During CMR scan, expected to be on average approx. 45 minutes, and the subsequent coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study start1 Oct 2014
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Balthasar Eberle, MD, Principal investigator, Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233634
- Sponsor's protocol ID
- 107/14
- Other IDs
- GUDD 1-14
- Acronym
- CADOS-CMR
- Status last verified
- Dec 2017
- First submitted
- 3 Sep 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23301055Guensch 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.
PubMed 24078154Guensch 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.
PubMed 24303170Luu 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.
PubMed 25104812Neill 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.
PubMed 1175266Momen 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.
PubMed 19168724Nakao 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.
PubMed 9294979Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.
PubMed 32089047Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, von Tengg-Kobligk H, Windecker S, Friedrich MG, Eberle B, Guensch DP. Feasibility of cardiovascular magnetic resonance to detect oxygenation deficits in patients with multi-vessel coronary artery disease triggered by breathing maneuvers. J Cardiovasc Magn Reson. 2018 May 7;20(1):31. doi: 10.1186/s12968-018-0446-y.
PubMed 29730991
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02233634
- Acronym / sponsor ID
- CADOS-CMR / 107/14
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Angiography, Magnetic Resonance Imaging, Oxygen, Hyperoxia, Carbon Dioxide, Apnea, Hyperventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD Patients | Active comparator | Drug: Oxygen, Other: Hyperventilation Breath-hold (HVBH), Other: HVBH with OxygenAdministration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds |
| Healthy Volunteers (Control Group) | Active comparator | Drug: Oxygen, Other: Hyperventilation Breath-hold (HVBH), Other: HVBH with OxygenAdministration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with known relevant coronary artery stenosis (defined by previous coronary angiography, QCA: reduction in lumen-diameter of the vessel >50%) with a scheduled intervention or operation to treat this stenosis (staged PCI or coronary artery bypass surgery)
- CMR feasible prior to intervention or surgery
- Age ≥18 years
- Written informed consent
- For healthy participants: Absence of cardiovascular and lung disease, and absence of medication with cardiovascular effects
Key exclusion criteria (13 listed)
- General Contraindication against MRI-Scans: (claustrophobia, ferromagnetic implants, clips, pacemakers, shrapnels, ophthalmic metal deposits)
- Pregnancy or inconclusive test result
- Age <18 years
- Inability to give informed consent
- Consumption of caffeine, tea, treatment of dipyridamol <12h before the scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups | Drug | CAD Patients, Healthy Volunteers (Control Group) |
| Hyperventilation Breath-hold (HVBH)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 | Other | CAD Patients, Healthy Volunteers (Control Group) |
| HVBH with Oxygen1 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 | Other | CAD Patients, Healthy Volunteers (Control Group) |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Background: PubMed 23301055Guensch 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.
- Background: PubMed 24078154Guensch 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.
- Background: PubMed 24303170Guensch 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.
- Background: PubMed 25104812Luu 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.
- Background: PubMed 1175266Neill 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.
- Background: PubMed 19168724Momen 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.
- Background: PubMed 9294979Nakao 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.
- Derived from this study: PubMed 32089047Guensch DP, Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, Erdoes G, Grani C, von Tengg-Kobligk H, Raber L, Eberle B. Effect of Hyperoxia on Myocardial Oxygenation and Function in Patients With Stable Multivessel Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e014739. doi: 10.1161/JAHA.119.014739. Epub 2020 Feb 22.
- Derived from this study: PubMed 29730991Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, von Tengg-Kobligk H, Windecker S, Friedrich MG, Eberle B, Guensch DP. Feasibility of cardiovascular magnetic resonance to detect oxygenation deficits in patients with multi-vessel coronary artery disease triggered by breathing maneuvers. J Cardiovasc Magn Reson. 2018 May 7;20(1):31. doi: 10.1186/s12968-018-0446-y.
- Explanation and Study Results of a Hyperventilation Breath-Hold in Healthy Volunteers as used in the protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balthasar Eberle, MD principal investigator
Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen, Hyperventilation Breath-hold (HVBH) and HVBH with Oxygen in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233634, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.