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Breathing-Induced Myocardial Oxygenation Reserve (B-MORE-Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050346
Recruitment Status : Suspended (The preliminary analysis is in progress. Sample size will be revised after data analysis.)
First Posted : February 10, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
University Hospital Heidelberg
Groote Schuur Hospital
King's College London
University of Wisconsin, Madison
Jewish General Hospital
Information provided by (Responsible Party):
Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease
Coronary Artery Disease

Detailed Description:

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol. It aims to investigate a new Cardiovascular Magnetic Resonance (CMR) technique, called oxygenation-sensitive CMR (OS-CMR).

OS-CMR is a T2*-sensitive CMR sequence based on the so-called blood-oxygen-level-dependent (BOLD) effect. Because de-oxygenated hemoglobin acts as an endogenous paramagnetic contrast agent, the signal intensity (SI) in OS-CMR images is linearly correlated with hemoglobin oxygenation in the tissue. An increase in deoxyhemoglobin results in an drop in SI in OS-CMR images, while an increase in tissue oxygenation results in an increase in SI.

Therefore, OS-CMR has been found capable of assessing myocardial oxygenation and is being increasingly used to identify the vascular response of the coronary circulation to different stimuli.

Very recently, OS-CMR was used to identify the coronary vascular response to specific breathing maneuvers. Specifically, a marked increase of myocardial oxygenation was observed during a long breath-hold following a 60s period of hyperventilation. The combination of these two maneuvers appear to induce consistent and detectable changes of myocardial oxygenation, based on CO2-mediated coronary vasoconstriction and vasodilation, while being well tolerated by participants.

In this study, the investigators will use breathing maneuvers as coronary vasoactive stimuli to assess the myocardial oxygenation changes induced by such maneuvers with OS-CMR.

The investigators aim to assess if the breathing-induced relative increase of myocardial oxygenation (Breathing-induced Myocardial Oxygenation REserve, B-MORE) in a coronary territory is clinically feasible to serve as a marker for the severity of coronary artery stenosis.

Moreover, the investigators will assess the feasibility and safety of OS-CMR with breathing maneuvers in patients with suspected coronary artery disease in a multi-center setting.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Breathing-Induced Myocardial Oxygenation Reserve - Pilot Study (B-MORE-Pilot)
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Group/Cohort
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.



Primary Outcome Measures :
  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. [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]
    Myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers


Secondary Outcome Measures :
  1. Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Fractional Flow Reserve (FFR) measurements in CAD patients [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]
    Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Fractional Flow Reserve (FFR) measurements

  2. Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Quantitative Coronary Angiography (QCA) measurements in CAD patients [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]
    Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Quantitative Coronary Angiography (QCA) measurements

  3. Presence of side effects during OS-CMR with breathing maneuvers [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]
    side effects experienced by the participants during breathing maneuvers

  4. Clinical feasibility of OS-CMR with breathing maneuvers [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]
    Number of participants who voluntarily stopped the maneuver prior to completion and scan time of the image acquisition protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050346


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, 3755
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
South Africa
Groote Schuur Hospital
Cape Town, South Africa, 7935
United Kingdom
King's College London
London, United Kingdom, WC2R 2LS
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
University Hospital Heidelberg
Groote Schuur Hospital
King's College London
University of Wisconsin, Madison
Jewish General Hospital
Investigators
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Principal Investigator: Matthias Friedrich, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications:

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Responsible Party: Matthias Friedrich, Chief, Cardiovascular Imaging, McGill University Health Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03050346    
Other Study ID Numbers: 15-398-MUHC
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Magnetic Resonance Imaging
Coronary Artery Disease
Apnea
Hyperventilation
BOLD
Breathing Maneuvers
Myocardial Oxygenation
Additional relevant MeSH terms:
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Respiratory Aspiration
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes