Breathing-Induced Myocardial Oxygenation Reserve (B-MORE-Pilot)

October 6, 2022 updated by: Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre

Breathing-Induced Myocardial Oxygenation Reserve - Pilot Study (B-MORE-Pilot)

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol, combined with a specific breathing maneuver to identify myocardial regions exposed to severe coronary artery stenosis.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol. It aims to investigate a new Cardiovascular Magnetic Resonance (CMR) technique, called oxygenation-sensitive CMR (OS-CMR).

OS-CMR is a T2*-sensitive CMR sequence based on the so-called blood-oxygen-level-dependent (BOLD) effect. Because de-oxygenated hemoglobin acts as an endogenous paramagnetic contrast agent, the signal intensity (SI) in OS-CMR images is linearly correlated with hemoglobin oxygenation in the tissue. An increase in deoxyhemoglobin results in an drop in SI in OS-CMR images, while an increase in tissue oxygenation results in an increase in SI.

Therefore, OS-CMR has been found capable of assessing myocardial oxygenation and is being increasingly used to identify the vascular response of the coronary circulation to different stimuli.

Very recently, OS-CMR was used to identify the coronary vascular response to specific breathing maneuvers. Specifically, a marked increase of myocardial oxygenation was observed during a long breath-hold following a 60s period of hyperventilation. The combination of these two maneuvers appear to induce consistent and detectable changes of myocardial oxygenation, based on CO2-mediated coronary vasoconstriction and vasodilation, while being well tolerated by participants.

In this study, the investigators will use breathing maneuvers as coronary vasoactive stimuli to assess the myocardial oxygenation changes induced by such maneuvers with OS-CMR.

The investigators aim to assess if the breathing-induced relative increase of myocardial oxygenation (Breathing-induced Myocardial Oxygenation REserve, B-MORE) in a coronary territory is clinically feasible to serve as a marker for the severity of coronary artery stenosis.

Moreover, the investigators will assess the feasibility and safety of OS-CMR with breathing maneuvers in patients with suspected coronary artery disease in a multi-center setting.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Montreal, Quebec, Canada, 3755
        • Jewish General Hospital
  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
  • South Africa
      • Cape Town, South Africa, 7935
        • Groote Schuur Hospital
  • United Kingdom
      • London, United Kingdom, WC2R 2LS
        • King's College London
  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients scheduled for a coronary angiography on the basis of cardiac symptoms and a test positive for inducible coronary ischemia, who show one-vessel or two-vessel CAD at coronary angiography.

Description

Inclusion Criteria:

  • Age > 18 y
  • Informed consent as documented by signature (Appendix Informed Consent Form)
  • Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia
  • One-vessel or two-vessel CAD at coronary angiography (For healthy volunteers: absence of current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects)

Exclusion Criteria:

  • General MRI contraindications (i.e pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy)
  • Acute Coronary Syndrome (ACS) or other acute cardiac injury within 4 weeks
  • Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery
  • Hemodynamically unstable conditions
  • Significant or uncontrolled arrhythmias
  • Lack of ability to follow commands
  • Vasoactive medication (e.g. nitro or ß blockers) or nutrition with caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 h before the exam
  • Non-ischemic cardiomyopathy
  • Severe Pulmonary Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CAD patients
Consecutive patients scheduled for a coronary angiography on the basis of cardiac symptoms and a test positive for inducible coronary ischemia, who are affected by one-vessel or two-vessel CAD at the time of the OS-CMR with breathing maneuvers (HVBH).
Healthy subjects
Subjects without current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers in CAD patients.
Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes
Myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers
OS-CMR with breathing maneuvers will last about 5-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Fractional Flow Reserve (FFR) measurements in CAD patients
Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes
Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Fractional Flow Reserve (FFR) measurements
OS-CMR with breathing maneuvers will last about 5-10 minutes
Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Quantitative Coronary Angiography (QCA) measurements in CAD patients
Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes
Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Quantitative Coronary Angiography (QCA) measurements
OS-CMR with breathing maneuvers will last about 5-10 minutes
Presence of side effects during OS-CMR with breathing maneuvers
Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes
side effects experienced by the participants during breathing maneuvers
OS-CMR with breathing maneuvers will last about 5-10 minutes
Clinical feasibility of OS-CMR with breathing maneuvers
Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes
Number of participants who voluntarily stopped the maneuver prior to completion and scan time of the image acquisition protocol.
OS-CMR with breathing maneuvers will last about 5-10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

King's College London
University of Wisconsin, Madison
University Hospital Heidelberg
Jewish General Hospital
Groote Schuur Hospital

Investigators

  • Principal Investigator: Matthias Friedrich, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

March 24, 2022

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-398-MUHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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