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Recruiting NCT04126148

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

— Observational Coronary Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity [Time frame: 2019-2022]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Canada · 1 center
  • McGill University Health Center — Montreal

Identifiers

NCT: NCT04126148 · 2019-4137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗