Actively Recruiting
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-10-24
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a non-invasive way to detect areas of reduced oxygen supply in the heart muscle caused by narrowed coronary arteries. This observational study focuses on assessing breathing maneuvers combined with Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) to see if they can serve as reliable indicators compared to the current clinical standards, Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR). Participants include healthy adults over 40 years without significant cardiovascular or respiratory issues, and patients over 18 years with suspected coronary artery disease who are scheduled for invasive coronary angiography. The study involves performing specific breathing exercises and imaging scans to measure heart oxygenation and function without using pharmaceutical agents. During the study, participants undergo OS-CMR imaging while performing breathing maneuvers to evaluate myocardial oxygenation changes. Researchers collect various measurements such as myocardial signal intensity changes, heart rate responses, and myocardial strain during breath-holds. The main goal is to determine diagnostic cut-off values for oxygenation changes that correlate with coronary artery narrowing. The study also monitors relationships between imaging results and clinical measures like FFR and iFR. Participation includes scheduled imaging visits and assessments up to the study's completion in 2024.
CONDITIONS
Brief Title
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants over 40 years old with no significant cardiovascular or respiratory health problems
- Patients over 18 years old scheduled for invasive coronary angiography due to symptoms or positive ischemia tests
You will not qualify if you...
- Presence of pacemakers, defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes
- Known or suspected pregnancy
- Caffeine consumption within 12 hours before the exam
- Regular nicotine use in the last 6 months
- Use of vasoactive medication within 12 hours prior to exam (patients only)
- Contraindications to adenosine such as certain heart blocks, sinus node disease, asthma, or bronchoconstrictive diseases
- Acute Coronary Syndrome or previous coronary artery bypass surgery
- Myocardial infarction within the past month
- Clinically unstable condition
- Significant or uncontrolled arrhythmia
- Patients only
- Exclusion for general MRI contraindications and health status as above
- Healthy volunteers must have no significant cardiovascular or respiratory problems
- Patients must meet angiography indication criteria
- No caffeine or nicotine use as specified
- No contraindications to study procedures or medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo breathing maneuvers and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) to assess myocardial oxygenation. These results will be compared to clinical gold standards.
1 visit (in-person)
Duration - Up to 3 years
Participants are observed for outcomes related to myocardial oxygenation reserve and heart rate response to hyperventilation over the study period.
Follow-up assessments as scheduled during the study period
Trial Site Locations
Total: 1 location
1
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
E
Elizabeth Konidis
A
Adonis Rodaros
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here