Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05516615
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2022-08-23
Brief Title:
The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCREEN-MORE
Brief Summary:
Breathing maneuvers ie 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 diseaseCAD 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None