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

Coronary Artery Stenosis Clinical Trial

— B-MORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126148
• Other study ID #: 2019-4137
• Status: Recruiting
• Start date: July 4, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Elizabeth Konidis
• Phone: 514 934-1934
• Email: elisavet.konidis[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Matthias Friedrich

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity	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	2019-2022
Secondary	30sec B-MORE Cut-off	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.	2019-2022
Secondary	Heart rate response to hyperventilation.	Markers of diagnostic accuracy will be obtained to assess the accuracy the heart rate response to hyperventilation.	2019-2022
Secondary	Myocardial strain response at the 15s and 30s time point during breath-hold	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	2019-2022
Secondary	Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold	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	2019-2022
Secondary	B-MORE - strain response at 15s and 30s time breath hold and Heart rate response	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	2019-2022
Secondary	Relationship between B-MORE vs heart rate response to hyperventilation	A student's t-test will assess the relationship between B-MORE results and heart rate response to hyperventilation	2019-2022
Secondary	Relationship between myocardial strain and Heart rate	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	2019-2022
Secondary	Relationship between B-MORE and myocardial strain measurements -each coronary territory	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.	2019-2022
Secondary	Global relationship between B-MORE results and myocardial strain measurements	A student's t-test will assess the global relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial).	2019-2022
Secondary	Relationship between B-MORE and QCA	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.	2019-2022
Secondary	Relationship between B-MORE and FFR / iFR	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.	2019-2022
Secondary	Relationship between B-MORE (15s and 30s) vs QCA	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.	2019-2022
Secondary	Relationship between B-MORE vs FFR - iFR each coronary territory	To assess the relationship between B-MORE results after hyperventilation and FFR / iFR measurements for each coronary territory.	2019-2022
Secondary	Relationship between B-MORE vs T1/T2 mapping	Pearson's assess the relationship between B-MORE results and global T1/T2 mapping measurements.	2019-2022
Secondary	Breathing maneuver - Clinical feasibility	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.	2019-2022
Secondary	B-MORE analysis intra and inter-reader reproducibility	Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of B-MORE.	2019-2022