Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
B-MORE
1 other identifier
observational
350
1 country
1
Brief Summary
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2019
CompletedFirst Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 24, 2024
October 1, 2024
5.4 years
October 11, 2019
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
To obtain a diagnostic cut-off of the mean Breathing-Maneuver-induced Myocardial Oxygenation REserve (B-MORE) of a coronary territory as defined by the relative change of myocardial signal intensity (delta SI\[%\]) in oxygenation-sensitive CMR (OS-CMR) images, at the 15s and 30s time point of a post-hyperventilation breath-hold for detecting an associated severe coronary artery stenosis as defined by FFR of less than 0.75 or a QCA assessment of \>0.75, as compared to the global delta SI\[%\] in age-matched healthy volunteers
2019-2022
Secondary Outcomes (16)
30sec B-MORE Cut-off
2019-2022
Heart rate response to hyperventilation.
2019-2022
Myocardial strain response at the 15s and 30s time point during breath-hold
2019-2022
Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold
2019-2022
B-MORE - strain response at 15s and 30s time breath hold and Heart rate response
2019-2022
- +11 more secondary outcomes
Study Arms (2)
Age matched Healthy participants (150)
Healthy Participants Age: \> 40y No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system
Coronary Artery Disease (CAD) Patients (200)
Coronary Artery Disease (CAD) Patients Age \> 18 y Patients with an Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.
Eligibility Criteria
Study population will be composed of patients with suspected or known CAD and healthy volunteers. The primary group will consist of patients with 1- or 2-vessel CAD. Patients diagnosed with 3-vessel or no obstructive disease in an angiography visit after the CMR exam will be included as a sub-group, with not more than 25% of the study population being in this group. Healthy volunteers will serve to act as a control for the assessment of a diagnostic cut-off. Patient who performed the CMR and then the angiography, who are deemed to have no obstructive (no vessel) CAD or 3-vessel CAD, will be assigned to a subgroup of the study. No vessel disease will be those who have no vessel stenosis of \>0.75. 3-vessel disease will be those who have a stenosis of \>0.75 in all three coronary arteries.
You may qualify if:
- Healthy Participants
- Age: \> 40y
- No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.
- CAD Patients
- Age \> 18 y
- Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.
You may not qualify if:
- ALL participants:
- General MRI contraindications: Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
- Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam.
- Regular nicotine consumption during the last 6 months.
- Patients only
- Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam Contraindications to adenosine (2nd or 3rd A-V block, sinus node disease, asthma, bronchoconstrictive diseases).
- Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
- Previous myocardial infarction within 1 month
- Clinically unstable condition
- Significant or uncontrolled arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias G Friedrich, MD
Reseach Institute of the McGill University health Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
July 4, 2019
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
October 24, 2024
Record last verified: 2024-10