Assessing oxygenation in heart muscle using breathing techniques
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
This study is testing if certain breathing techniques can help check the oxygen levels in the heart muscle of patients who might have blocked arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04126148 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of breathing maneuvers as a method to assess myocardial oxygenation in patients suspected of having coronary artery stenosis. It utilizes Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) to identify areas of oxygenation deficit in the heart muscle, comparing the results to the established clinical standards of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR). The goal is to validate a non-invasive imaging technique that could improve diagnostic accuracy for coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptoms indicating coronary artery disease and a positive test for inducible ischemia.
Not a fit: Patients with significant medical conditions affecting cardiovascular or respiratory systems, or those with contraindications to MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive diagnostic tool for identifying myocardial oxygenation issues in patients with coronary artery stenosis.
How similar studies have performed: While the approach of using breathing maneuvers for myocardial assessment is innovative, similar studies have shown promise in non-invasive imaging techniques for cardiac evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Where this trial is running
Montreal, Quebec
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Matthias G Friedrich, MD — Reseach Institute of the McGill University health Center
- Study coordinator: Elizabeth Konidis
- Email: elisavet.konidis@muhc.mcgill.ca
- Phone: 514 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.