Clinical trial NCT04126148: Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
Official title: Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Stenosis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
timeFrame: 2019-2022
Secondary outcomes:
measure: 30sec B-MORE Cut-off
timeFrame: 2019-2022
measure: Heart rate response to hyperventilation.
timeFrame: 2019-2022
measure: Myocardial strain response at the 15s and 30s time point during breath-hold
timeFrame: 2019-2022
measure: Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold
timeFrame: 2019-2022
measure: B-MORE - strain response at 15s and 30s time breath hold and Heart rate response
timeFrame: 2019-2022
measure: Relationship between B-MORE vs heart rate response to hyperventilation
timeFrame: 2019-2022
measure: Relationship between myocardial strain and Heart rate
timeFrame: 2019-2022
measure: Relationship between B-MORE and myocardial strain measurements -each coronary territory
timeFrame: 2019-2022
measure: Global relationship between B-MORE results and myocardial strain measurements
timeFrame: 2019-2022
measure: Relationship between B-MORE and QCA
timeFrame: 2019-2022
measure: Relationship between B-MORE and FFR / iFR
timeFrame: 2019-2022
measure: Relationship between B-MORE (15s and 30s) vs QCA
timeFrame: 2019-2022
measure: Relationship between B-MORE vs FFR - iFR each coronary territory
timeFrame: 2019-2022
measure: Relationship between B-MORE vs T1/T2 mapping
timeFrame: 2019-2022
measure: Breathing maneuver - Clinical feasibility
timeFrame: 2019-2022
measure: B-MORE analysis intra and inter-reader reproducibility
timeFrame: 2019-2022
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Reseach Institute of the McGill University health Center
name: Matthias G Friedrich, MD
role: PRINCIPAL_INVESTIGATOR
References: