Breathing-Induced Myocardial Oxygenation Reserve

NCT03050346 | Completed

• 1 other identifier: 15-398-MUHC
• Study Type: observational
• Target: 113
• Locations: 5 countries
• Sites: 6

Brief Summary

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol, combined with a specific breathing maneuver to identify myocardial regions exposed to severe coronary artery stenosis.

Conditions

Coronary Artery Disease

Keywords

Magnetic Resonance Imaging; Coronary Artery Disease; Apnea; Hyperventilation; BOLD; Breathing Maneuvers; Myocardial Oxygenation

Outcome Measures

Primary Outcomes (1)

• Comparison of myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers in CAD patients.

  Myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers

  OS-CMR with breathing maneuvers will last about 5-10 minutes

Secondary Outcomes (4)

• Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Fractional Flow Reserve (FFR) measurements in CAD patients

  OS-CMR with breathing maneuvers will last about 5-10 minutes

• Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Quantitative Coronary Angiography (QCA) measurements in CAD patients

  OS-CMR with breathing maneuvers will last about 5-10 minutes

• Presence of side effects during OS-CMR with breathing maneuvers

  OS-CMR with breathing maneuvers will last about 5-10 minutes

• Clinical feasibility of OS-CMR with breathing maneuvers

  OS-CMR with breathing maneuvers will last about 5-10 minutes

Study Arms (2)

CAD patients

Consecutive patients scheduled for a coronary angiography on the basis of cardiac symptoms and a test positive for inducible coronary ischemia, who are affected by one-vessel or two-vessel CAD at the time of the OS-CMR with breathing maneuvers (HVBH).

Healthy subjects

Subjects without current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects.

Eligibility Criteria

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

Study Population

Consecutive patients scheduled for a coronary angiography on the basis of cardiac symptoms and a test positive for inducible coronary ischemia, who show one-vessel or two-vessel CAD at coronary angiography.

You may qualify if:

• Age \> 18 y
• Informed consent as documented by signature (Appendix Informed Consent Form)
• Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia
• One-vessel or two-vessel CAD at coronary angiography (For healthy volunteers: absence of current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects)

You may not qualify if:

• General MRI contraindications (i.e pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy)
• Acute Coronary Syndrome (ACS) or other acute cardiac injury within 4 weeks
• Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery
• Hemodynamically unstable conditions
• Significant or uncontrolled arrhythmias
• Lack of ability to follow commands
• Vasoactive medication (e.g. nitro or ß blockers) or nutrition with caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 h before the exam
• Non-ischemic cardiomyopathy
• Severe Pulmonary Disease

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• University Hospital Heidelberg: collaborator
• Groote Schuur Hospital: collaborator
• King's College London: collaborator
• University of Wisconsin, Madison: collaborator
• Jewish General Hospital: collaborator

Study Sites (6)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Jewish General Hospital

Montreal, Quebec, 3755, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Groote Schuur Hospital

Cape Town, 7935, South Africa

Location

King's College London

London, WC2R 2LS, United Kingdom

Location

Related Publications (11)

• Friedrich MG, Niendorf T, Schulz-Menger J, Gross CM, Dietz R. Blood oxygen level-dependent magnetic resonance imaging in patients with stress-induced angina. Circulation. 2003 Nov 4;108(18):2219-23. doi: 10.1161/01.CIR.0000095271.08248.EA. Epub 2003 Oct 13.

  PMID: 14557359 BACKGROUND

• Arnold JR, Karamitsos TD, Bhamra-Ariza P, Francis JM, Searle N, Robson MD, Howells RK, Choudhury RP, Rimoldi OE, Camici PG, Banning AP, Neubauer S, Jerosch-Herold M, Selvanayagam JB. Myocardial oxygenation in coronary artery disease: insights from blood oxygen level-dependent magnetic resonance imaging at 3 tesla. J Am Coll Cardiol. 2012 May 29;59(22):1954-64. doi: 10.1016/j.jacc.2012.01.055.

  PMID: 22624835 BACKGROUND

• Friedrich MG, Karamitsos TD. Oxygenation-sensitive cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 May 24;15(1):43. doi: 10.1186/1532-429X-15-43.

  PMID: 23706167 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

• 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

• Fischer K, Guensch DP, Friedrich MG. Response of myocardial oxygenation to breathing manoeuvres and adenosine infusion. Eur Heart J Cardiovasc Imaging. 2015 Apr;16(4):395-401. doi: 10.1093/ehjci/jeu202. Epub 2014 Oct 21.

  PMID: 25336541 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

• Sueda S, Saeki H, Otani T, Ochi N, Kukita H, Kawada H, Matsuda S, Uraoka T. Investigation of the most effective provocation test for patients with coronary spastic angina: usefulness of accelerated exercise following hyperventilation. Jpn Circ J. 1999 Feb;63(2):85-90. doi: 10.1253/jcj.63.85.

  PMID: 10084369 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

• Chauhan A, Mullins PA, Taylor G, Petch MC, Schofield PM. Effect of hyperventilation and mental stress on coronary blood flow in syndrome X. Br Heart J. 1993 Jun;69(6):516-24. doi: 10.1136/hrt.69.6.516.

  PMID: 8343318 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Apnea; Hyperventilation

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthias Friedrich, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiovascular Imaging, McGill University Health Centre

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: March 24, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

CA (2); US (1); DE (1); GB (1); ZA (1)