Coronary Artery StenosisB-MORENCT04126148
Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
An observational study of Coronary Artery Stenosis, run by Matthias Friedrich at 8 sites in 7 countries.
Trial summary
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Stenosis
- How many people
- 236 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 4 Jul 2019to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
- Previous myocardial infarction within 1 month
- Clinically unstable condition
- Significant or uncontrolled arrhythmia
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Canada2 sites
McGill University Health Center
Montreal, Quebec, H4A 3J1
Sunnybrook Research Institute
Toronto, Ontario, M4N3M5
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
Read the detailed description
This observational applied research international study aims to assess the validity of breathing maneuvers as a vasoactive maneuver and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) in a patient population. OS-CMR results will be compared to the clinical gold standard of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR) as a secondary objective, to determine if this non-invasive, no pharmaceutical agent imaging technique can identify areas of oxygenation deficit in myocardium perfused by a stenosed coronary artery.
- Conditions
- Coronary Artery Stenosis
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2019-2022
Secondary outcomes (16)
30sec B-MORE Cut-off
A student's t-test will assess a cut-off of the Breathing maneuver induced Myocardial Oxygenation REserve (MORE), at the 30s time point of the breath hold, for a region perfused by a stenosed coronary artery (FFR / iFR or QCA >0.75) as compared to a healthy coronary artery (FFR / iFR or QCA <0.75), within a patient.
Measured: 2019-2022
Heart rate response to hyperventilation.
Markers of diagnostic accuracy will be obtained to assess the accuracy the heart rate response to hyperventilation.
Measured: 2019-2022
Myocardial strain response at the 15s and 30s time point during breath-hold
Markers of diagnostic accuracy will be obtained to assess the accuracy of the myocardial strain response at the 15s and 30s time point of the breath-hold
Measured: 2019-2022
Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold
Markers of diagnostic accuracy will be obtained to assess the accuracy of a combination of the B-MORE and the strain response at the 15s and 30s time point of the breath-hold
Measured: 2019-2022
B-MORE - strain response at 15s and 30s time breath hold and Heart rate response
Markers of diagnostic accuracy will be obtained to assess the accuracy of a combination of the B-MORE, the strain response at the 15s and 30s time point of the breath-hold, and the heart rate response to hyperventilation
Measured: 2019-2022
Relationship between B-MORE vs heart rate response to hyperventilation
A student's t-test will assess the relationship between B-MORE results and heart rate response to hyperventilation
Measured: 2019-2022
Relationship between myocardial strain and Heart rate
A student's t-test will assess the relationship between the strain response at the 15 and 30 s timepoints and heart rate response to hyperventilation
Measured: 2019-2022
Relationship between B-MORE and myocardial strain measurements -each coronary territory
A student's t-test will assess the relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial) at the 15s and 30s time point for each coronary territory.
Measured: 2019-2022
Global relationship between B-MORE results and myocardial strain measurements
A student's t-test will assess the global relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial).
Measured: 2019-2022
Relationship between B-MORE and QCA
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results at the 15s and 30s time point of the breath-hold and Quantitative Coronary Angiography (QCA) measurements for each coronary territory.
Measured: 2019-2022
Relationship between B-MORE and FFR / iFR
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results at the 15 s and 30s time point of the breath-hold and FFR / iFR measurements for each coronary territory.
Measured: 2019-2022
Relationship between B-MORE (15s and 30s) vs QCA
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results after hyperventilation and Quantitative Coronary Angiography (QCA) measurements for each coronary territory.
Measured: 2019-2022
Relationship between B-MORE vs FFR - iFR each coronary territory
To assess the relationship between B-MORE results after hyperventilation and FFR / iFR measurements for each coronary territory.
Measured: 2019-2022
Relationship between B-MORE vs T1/T2 mapping
Pearson's assess the relationship between B-MORE results and global T1/T2 mapping measurements.
Measured: 2019-2022
Breathing maneuver - Clinical feasibility
Recorded time, exclusion rate due to inability to perform the breathing maneuvers, will be reported for clinical feasibility during MRI and while performing iFR. Any serious adverse effects of the breathing maneuver will be reported for safety.
Measured: 2019-2022
B-MORE analysis intra and inter-reader reproducibility
Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of B-MORE.
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start4 Jul 2019
- Primary completion13 Jan 2026
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthias Friedrich
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, Flinders Medical Centre, Sunnybrook Research Institute, University of Leicester, Clinica Cardio VID, Ippokration General Hospital, Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Matthias Friedrich, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126148
- Sponsor's protocol ID
- 2019-4137
- Acronym
- B-MORE
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
- ClinicalTrials.gov ID
- NCT04126148
- Acronym / sponsor ID
- B-MORE / 2019-4137
- Conditions
- Coronary Artery Stenosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Matthias FriedrichUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, Flinders Medical Centre, Sunnybrook Research Institute, University of Leicester, Clinica Cardio VID, Ippokration General Hospital, Charite University, Berlin, Germany
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
Detailed description
This observational applied research international study aims to assess the validity of breathing maneuvers as a vasoactive maneuver and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) in a patient population. OS-CMR results will be compared to the clinical gold standard of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR) as a secondary objective, to determine if this non-invasive, no pharmaceutical agent imaging technique can identify areas of oxygenation deficit in myocardium perfused by a stenosed coronary artery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
Time frame: 2019-2022
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
16 secondary outcomes
30sec B-MORE Cut-off
Time frame: 2019-2022
Heart rate response to hyperventilation.
Time frame: 2019-2022
Myocardial strain response at the 15s and 30s time point during breath-hold
Time frame: 2019-2022
Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold
Time frame: 2019-2022
B-MORE - strain response at 15s and 30s time breath hold and Heart rate response
Time frame: 2019-2022
Relationship between B-MORE vs heart rate response to hyperventilation
Time frame: 2019-2022
Relationship between myocardial strain and Heart rate
Time frame: 2019-2022
Relationship between B-MORE and myocardial strain measurements -each coronary territory
Time frame: 2019-2022
Global relationship between B-MORE results and myocardial strain measurements
Time frame: 2019-2022
Relationship between B-MORE and QCA
Time frame: 2019-2022
Relationship between B-MORE and FFR / iFR
Time frame: 2019-2022
Relationship between B-MORE (15s and 30s) vs QCA
Time frame: 2019-2022
Relationship between B-MORE vs FFR - iFR each coronary territory
Time frame: 2019-2022
Relationship between B-MORE vs T1/T2 mapping
Time frame: 2019-2022
Breathing maneuver - Clinical feasibility
Time frame: 2019-2022
B-MORE analysis intra and inter-reader reproducibility
Time frame: 2019-2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Friedrich, MD principal investigator
Research Institute of the McGill University Health Centre
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenosis, run by Matthias Friedrich at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United States, Australia, Colombia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity (time frame: 2019-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.