- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516615
The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits (SCREEN-MORE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4A 3J1
- The Research Institute of the McGill University Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Healthy volunteers:
- Aged > 35
- No known current or pre-existing problems that would affect the cardiovascular or respiratory system
Patient population:
- Aged > 35
- Clinically indicated referral for adenosine stress first-pass perfusion MRI in subjects with known or suspected coronary artery disease
Exclusion Criteria:
Healthy Volunteers:
- MR incompatible devices such as pacemakers, defibrillators, implanted material, or foreign bodies.
- Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam
- Presence of cardiovascular disease.
- Regular nicotine consumption during the last 6 months
Patient Population:
- MR incompatible devices such as pacemakers, defibrillators, implanted material, or foreign bodies.
- Vasoactive medication (e.g. nitrate, beta-blocker, calcium channel blocker) during the 12 hours prior to the exam.
- Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam
- Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
- Previous myocardial infarction within one month
- Clinically unstable condition
- Significant or uncontrolled arrhythmia
- Patients who are pregnant
- Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
- Left bundle branch block (LBBB)
- Established valvular regurgitation or stenosis abnormality above moderate severity
- Patients with a known history of heart failure (Ejection fraction<40%)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy volunteers
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the negative predictive value of the heart rate acceleration in response to 1-min hyperventilation
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 |
June 2020 - August 2021
|
To assess the negative predictive value of the heart rate recovery in response to maximal voluntary 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 recovery in response to maximal voluntary breath-hold to identify its ability to rule out myocardial perfusion deficit |
June 2020 - August 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the negative predictive value of heart rate variability during 4-min breathing maneuver to rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers
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
|
June 2020 - August 2021
|
To assess the negative predictive value of the combination of INTERHEART risk score and HR response to breathing maneuver to rule out the presence of inducible 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
|
June 2020 - August 2021
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the myocardial oxygenation changes in OS-CMR images between healthy volunteers and patients with suspected or known CAD
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
|
June 2020 - August 2021
|
To assess the relationship between myocardial oxygenation changes in OS-CMR images with perfusion deficit in adenosine stress first-pass perfusion MRI
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
|
June 2020 - August 2021
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-6487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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