Coronary Artery DiseaseSCREEN-MORENCT05516615
The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits
An observational study of Coronary Artery Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 4 minute breathing maneuver
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2020to 18 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with known or suspected Coronary Artery Disease (CAD) aged more than 35.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 18Show fewer
- 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%)
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3J1
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- 4 minute breathing maneuver
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 minute breathing maneuverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | 1. Aged more than 35
2. No known current or pre-existing problems that would affect the cardiovascular or respiratory system Receives: Other: 4 minute breathing maneuver | |
| Patient population | 1. Aged more than 35
2. Referral of subjects with known or suspected CAD for adenosine stress first-pass perfusion MRI based on the clinical judgement of their referring physician Receives: Other: 4 minute breathing maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the negative predictive value of the heart rate acceleration in response to 1-min hyperventilation
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
Measured: June 2020 - August 2021
To assess the negative predictive value of the heart rate recovery in response to maximal voluntary breath-hold
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
Measured: June 2020 - August 2021
Secondary outcomes (2)
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
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
Measured: 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
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
Measured: June 2020 - August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start14 Jul 2020
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516615
- Sponsor's protocol ID
- 2020-6487
- Acronym
- SCREEN-MORE
- Status last verified
- Jan 2024
- First submitted
- 23 Aug 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits
- ClinicalTrials.gov ID
- NCT05516615
- Acronym / sponsor ID
- SCREEN-MORE / 2020-6487
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: 4 minute breathing maneuver1. Aged more than 35 2. No known current or pre-existing problems that would affect the cardiovascular or respiratory system |
| Patient population | – | Other: 4 minute breathing maneuver1. Aged more than 35 2. Referral of subjects with known or suspected CAD for adenosine stress first-pass perfusion MRI based on the clinical judgement of their referring physician |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with known or suspected Coronary Artery Disease (CAD) aged more than 35.
Key inclusion criteria (6 listed)
- Healthy volunteers:
- Aged > 35
- Clinically indicated referral for adenosine stress first-pass perfusion MRI in subjects with known or suspected coronary artery disease
Key exclusion criteria (18 listed)
- 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
- MR incompatible devices such as pacemakers, defibrillators, implanted material, or foreign bodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 minute breathing maneuverThe 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. | Other | Healthy volunteers, Patient population |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the negative predictive value of the heart rate acceleration in response to 1-min hyperventilation (time frame: June 2020 - August 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.