The Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
NCT Number: NCT05516615
Breathing maneuvers, i.e. hyperventilation followed by breath-holding, have been shown to change coronary dynamics; hyperventilating narrows the coronary arteries, puts "stress" on the heart, and increases the heart rate, whereas breath-hold dilates the coronary arteries and decreases the heart rate," rest". Heart rate response to hyperventilation has been reported to have high diagnostic accuracy to rule out heart disease. The cardiac stress test, the modality of choice for the initial assessment of patients with suspected coronary artery disease(CAD), is routinely overprescribed by physicians, which exerts a financial burden on the healthcare system. Hence, developing an inexpensive, reliable, and available tool-HR response to breathing maneuvers- may avoid unnecessary referrals for cardiac stress tests by an effective differentiation of patients with CAD from healthy people. This study aims to assess the negative predictive value of the HR response to a 4-minute breathing maneuver for inducible myocardial ischemia, avoiding further stress testing as a gatekeeper.
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Notify Me35 year and older
All sexes
Observational
Montreal, Quebec, H4A 3J1, Canada
Patients with suspected CAD must have a clinical indication for cardiac stress test based on the clinical judgement of their referring physician and be referred to adenosine stress first-pass perfusion MRI located at the McGill University Health Centre (MUHC). Healthy participants must have no known history of cardiovascular or respiratory diseases. At the time of recruitment, eligible participants will perform the 4-minute breathing maneuver, comprised of 2 minutes of normal breathing and 1-min hyperventilation (rate of 30 breaths or more per minute) followed by a maximal breath-hold. A portable FDA-approved device will be used to record HR and respiration patterns during breathing maneuvers, which enables us to observe the beat-to-beat HR changes during each phase of the breathing maneuvers. On the same day, the participants' socio-demographics, medications, medical history and INTERHEART risk scores will be obtained. Afterwards, patients referred for a stress test will undergo adenosine stress first-pass perfusion MRI as prescribed by their referring physician to validate the findings of the breathing maneuver and detect CAD. Inside the MRI, the participants will also be asked to perform the same 4-min breathing maneuver during Oxygenation Sensitive-Cardiac Magnetic Resonance imaging (OS-CMR) protocol. This imaging technique provides a non-invasive assessment of myocardial oxygenation, relying on the paramagnetic features of deoxygenated hemoglobin as the intrinsic contrast agent.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient population:
Exclusion criteria
Healthy Volunteers:
Patient Population:
The 4-minute breathing maneuver comprised of 2 minutes of normal breathing and 1-min hyperventilation (rate of 30 breaths or more per minute) followed by a maximal breath-hold.
Time frame: June 2020 - August 2021
To rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers
A ROC analysis will provide an optimal cut-point value for the level of heart rate acceleration in response to 1-min hyperventilation to identify its ability to rule out myocardial perfusion deficit
Time frame: June 2020 - August 2021
To rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers
A ROC analysis will provide an optimal cut-point value for the level of heart rate recovery in response to maximal voluntary breath-hold to identify its ability to rule out myocardial perfusion deficit
Time frame: June 2020 - August 2021
ROC analysis will provide an optimal cut-point value for heart rate variability during 4-min breathing maneuver to identify its ability to rule out myocardial perfusion deficit
Time frame: June 2020 - August 2021
ROC analysis will provide an optimal cut-point value for the combination of INTERHEART risk score and HR response to breathing maneuver to identify its ability to rule out myocardial perfusion deficit
Time frame: June 2020 - August 2021
A student's t-test will compare the myocardial oxygenation changes between healthy volunteers and patients with suspected or known CAD
Time frame: June 2020 - August 2021
Pearson Correlation Coefficient will assess the correlation between myocardial oxygenation changes in OS-CMR with perfusion deficits in adenosine stress first-pass perfusion MRI
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Acronym: SCREEN-MORE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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