Status:

RECRUITING

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

Lead Sponsor:

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

Conditions:

Coronary Artery Stenosis

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 4 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT04126148

Start Date

July 4 2019

End Date

December 1 2024

Last Update

October 24 2024

Active Locations (1)

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1

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1