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

McGill University

Status: Enrolling

Conditions: Coronary Artery Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT04126148

2019-4137

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

Age matched Healthy participants (150)

Description:

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)

Description:

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.