Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease

NCT02233634 | Completed

• 2 other identifiers: 107/14GUDD 1-14
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease

Keywords

Coronary Angiography; Magnetic Resonance Imaging; Oxygen; Hyperoxia; Carbon Dioxide; Apnea; Hyperventilation

Outcome Measures

Primary Outcomes (1)

• Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration

  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

  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

  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)

  During CMR scan, expected to be on average approx. 45 minutes, and the subsequent coronary angiography

Study Arms (2)

CAD Patients

ACTIVE COMPARATOR

Administration of Oxygen via a mask, Hyperventilation, Combination of Oxygen administration and Hyperventilation, long breath-holds

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

Drug: Oxygen; Other: Hyperventilation Breath-hold (HVBH); Other: HVBH with Oxygen

Interventions

Oxygen DRUG

Oxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups

CAD Patients; Healthy Volunteers (Control Group)

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

CAD Patients; Healthy Volunteers (Control Group)

HVBH with Oxygen OTHER

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

CAD Patients; Healthy Volunteers (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Guensch 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.

  PMID: 32089047 DERIVED

• Fischer 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.

  PMID: 29730991 DERIVED

Related Links

• Explanation and Study Results of a Hyperventilation Breath-Hold in Healthy Volunteers as used in the protocol

MeSH Terms

Conditions

Coronary Artery Disease; Hyperoxia; Apnea; Hyperventilation

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Balthasar Eberle, MD

  Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 8, 2014
• Study Start: October 1, 2014
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

CH (1)