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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2022 |
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Main ID: |
NCT03050346 |
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Date of registration:
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08/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Breathing-Induced Myocardial Oxygenation Reserve
B-MORE-Pilot |
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Scientific title:
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Breathing-Induced Myocardial Oxygenation Reserve - Pilot Study (B-MORE-Pilot) |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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113 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03050346 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Germany
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South Africa
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United Kingdom
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United States
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Contacts
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Name:
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Matthias Friedrich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Centre/Research Institute of the McGill University Health Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Clinical feasibility of OS-CMR with breathing maneuvers
[Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes]
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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]
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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]
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Presence of side effects during OS-CMR with breathing maneuvers
[Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes]
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Secondary ID(s)
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15-398-MUHC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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