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NCT Number: NCT04126148

Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)

The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.

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Key information

Conditions

Coronary Artery Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 30sec B-MORE Cut-off

    Time frame: 2019-2022

    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.

  2. Heart rate response to hyperventilation.

    Time frame: 2019-2022

    Markers of diagnostic accuracy will be obtained to assess the accuracy the heart rate response to hyperventilation.

  3. Myocardial strain response at the 15s and 30s time point during breath-hold

    Time frame: 2019-2022

    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

  4. Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold

    Time frame: 2019-2022

    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

  5. B-MORE - strain response at 15s and 30s time breath hold and Heart rate response

    Time frame: 2019-2022

    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

  6. Relationship between B-MORE vs heart rate response to hyperventilation

    Time frame: 2019-2022

    A student's t-test will assess the relationship between B-MORE results and heart rate response to hyperventilation

  7. Relationship between myocardial strain and Heart rate

    Time frame: 2019-2022

    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

  8. Relationship between B-MORE and myocardial strain measurements -each coronary territory

    Time frame: 2019-2022

    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.

  9. Global relationship between B-MORE results and myocardial strain measurements

    Time frame: 2019-2022

    A student's t-test will assess the global relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial).

  10. Relationship between B-MORE and QCA

    Time frame: 2019-2022

    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.

  11. Relationship between B-MORE and FFR / iFR

    Time frame: 2019-2022

    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.

  12. Relationship between B-MORE (15s and 30s) vs QCA

    Time frame: 2019-2022

    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.

  13. Relationship between B-MORE vs FFR - iFR each coronary territory

    Time frame: 2019-2022

    To assess the relationship between B-MORE results after hyperventilation and FFR / iFR measurements for each coronary territory.

  14. Relationship between B-MORE vs T1/T2 mapping

    Time frame: 2019-2022

    Pearson's assess the relationship between B-MORE results and global T1/T2 mapping measurements.

  15. Breathing maneuver - Clinical feasibility

    Time frame: 2019-2022

    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.

  16. B-MORE analysis intra and inter-reader reproducibility

    Time frame: 2019-2022

    Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of B-MORE.

Study contacts

Contact information is provided by the study sponsor or research team.

Adonis Rodaros

CONTACT

[email protected]

514 934-1934 ext. 37305

Elizabeth Konidis

CONTACT

[email protected]

514 934-1934 ext. 37305

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Acronym: B-MORE

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2019
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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